To review the use of paliperidone palmitate in treatment of patients with schizophrenia. Methods:... more To review the use of paliperidone palmitate in treatment of patients with schizophrenia. Methods: Published clinical trial data for the development and utilization of paliperidone palmitate for the treatment of schizophrenia were assessed in this review. Four short-term, randomized, double-blind, placebo-controlled trials investigated the efficacy of paliperidone palmitate in acute exacerbation of schizophrenia. Paliperidone palmitate was also studied as a maintenance treatment to prevent or delay relapse in stable schizophrenia. In addition, paliperidone palmitate was compared to risperidone long-acting injection for noninferiority in three studies. Results: Paliperidone palmitate has been shown to be effective in reducing symptoms as measured by the Positive and Negative Syndrome Scale total scores in the four acute treatment studies. In the maintenance treatment studies, paliperidone palmitate was found to be more effective than placebo in preventing or delaying the time to first relapse in stable schizophrenia patients. In addition, paliperidone palmitate was shown to be noninferior to risperidone long-acting injection in two studies. It was shown to be reasonably well tolerated in all clinical trials. Acute treatment phase should be initiated with a dose of 234 mg on day one and 156 mg on day eight, followed by a recommended monthly maintenance dose of 39-234 mg based on efficacy and tolerability results from the clinical studies. Providing an optimal long-term treatment can be challenging. Paliperidone palmitate can be used as an acute treatment even in outpatient setting, and it has shown to be well tolerated by patients. Also, it does not require overlapping oral antipsychotic supplementation while being initiated, and is dosed once per month.
Background: A randomized, controlled, phase 3b study (ALPINE) evaluated efficacy and safety of a ... more Background: A randomized, controlled, phase 3b study (ALPINE) evaluated efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) using a 1-day initiation regimen in patients hospitalized for an acute exacerbation of schizophrenia. Paliperidone palmitate (PP) was used as an active control. Exploratory endpoint assessments included severity of illness, positive and negative symptoms, quality of life, caregiver burden, and satisfaction with medication. Methods: Adults were randomly assigned to AL 1064 mg q8wk or PP 156 mg q4wk as inpatients, discharged after 2 weeks, and followed through week 25. Exploratory efficacy measures included the 3 original PANSS subscales, Clinical Global Impression−Severity (CGI-S) subscale, and caregiver Burden Assessment Scale. Exploratory patientreported outcomes (PROs) included the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) and the Medication Satisfaction Questionnaire. Within-group changes from baseline through week 25 were analyzed for AL and PP separately. PROs were summarized based on observed data.
Payne Whitney Psychiatric Clinic in New York City. He is also a project psychiatrist on a Nationa... more Payne Whitney Psychiatric Clinic in New York City. He is also a project psychiatrist on a National Institute of Mental Health multicenter outpatient schizophrenia study and is conducting research on noncompliance and extrapyramidal disorders. The patient Ms. M, a 22-year-old single file clerk living with her parents, was admitted to an acute inpatient psychiatric unit with florid psychosis after rejection by a boyfriend. She presented with delusions of thought insertion and control from the spirit of her brother, who had died 15 years earlier, and the paranoid delusion that her food was poisoned by her father. For the week before admission, her parents refrained from seeking treatment for her despite her symptoms, but one night Ms. M left home, took the family car, and drove through the night to her brother's grave 300 miles away. On her return the next day, her parents brought her to the hospital, where she was admitted. Ms. M's parents reported that
... and should not be dismissed as an emo-tional disturbance (3). Psychotro-pic medications are e... more ... and should not be dismissed as an emo-tional disturbance (3). Psychotro-pic medications are etiologically implicated in the swallowing disor-ders of patients with Parkinson's disease and tadive dyskinesia by a variety ofpathophysiologic factors. First, dysphagia is present in ...
Few investigations have assessed the neuropsychological effects of psychotropic medications on sc... more Few investigations have assessed the neuropsychological effects of psychotropic medications on schizophrenic patients. In this study, 44 clinically stable schizophrenic inpatients were administered a battery of neuropsychological tests, and their performance was correlated with dosage of neuroleptic medication and benztropine. Neuroleptic dose was correlated with poorer performance on tests of psychomotor speed and attention, and with the number of perserverative errors on the Wisconsin Card Sort. Anticholinergic dose was associated with poorer verbal learning, verbal fluency, and motor speed. Both medication dosages were associated with poorer verbal recognition memory, but this association was strongly influenced by the performance of individuals on the highest medication doses. The findings, which were independent of clinical state and intelligence, indicate that higher doses of neuroleptic and anticholinergic medications are associated with poorer neuropsychological functioning in schizophrenia.
Nonadherence to antipsychotic medications in serious, persistent mental illness remains a signifi... more Nonadherence to antipsychotic medications in serious, persistent mental illness remains a significant clinical challenge. Long-acting therapy was developed to help improve adherence to schizophrenia therapy and provide an effective means for ameliorating symptoms and preventing relapse. The Agency for Health Care Policy and Research/National Institute of Mental Health Schizophrenia Patient Outcomes Research Team recommends that antipsychotic long-acting therapy be strongly considered for patients who have difficulty adhering to an oral medication regimen or who prefer long-acting therapy. Depot conventional formulations have long been available; for clinicians and patients who would rather use an atypical antipsychotic, studies with risperidone long-acting therapy suggest that it is efficacious and well tolerated. A common concern of clinicians who elect to initiate long-acting therapy is how to introduce the possibility of changing from the current oral antipsychotic to an long-act...
The objective of this study was to evaluate the relationship between compliance with an antipsych... more The objective of this study was to evaluate the relationship between compliance with an antipsychotic medication regimen and risk of hospitalization in a cohort of California Medicaid patients with schizophrenia. Methods: Compliance behavior was estimated by using a retrospective review of California Medicaid pharmacy refill and medical claims for 4,325 outpatients for whom antipsychotics were prescribed for treatment of schizophrenia from 1999 to 2001. Compliance behavior was estimated by using four different definitions: gaps in medication therapy, medication consistency and persistence, and a medication possession ratio. Patients were followed for one year and had an average of 19.1 dispensing events. Logistic regression models using each compliance estimate were used to determine the odds of hospitalization. Results: Risk of hospitalization was significantly correlated with compliance. With all definitions, lower compliance was associated with a greater risk of hospitalization over and above any other risk factors for hospitalization. For example, the presence of any gap in medication coverage was associated with increased risk of hospitalization, including gaps as small as one to ten days (odds ratio [OR]=1.98). A gap of 11 to 30 days was associated with an OR of 2.81, and a gap of more than 30 days was associated with an OR of 3.96. Conclusions: This study showed a direct correlation between estimated partial compliance and hospitalization risk among patients with schizophrenia across a continuum of compliance behavior. (Psychiatric Services 55:886-891, 2004)
In this column, the authors elaborate on how cognitive therapy can be adapted for patients with s... more In this column, the authors elaborate on how cognitive therapy can be adapted for patients with schizophrenia and discuss some considerations about the availability of cognitive therapy in the United Kingdom and the United States. Beneficial aspects of cognitive therapy for these patients include developing ongoing relationships with therapists who engage the patients in understanding their delusions and hallucinations and relating these experiences, which appear bizarre to others but are not recognized as such by the patient, to their real life experiences. This process may enable patients to gain perspective on their symptoms and employ the healthier parts of their thinking in managing their illness and their life circumstances. The authors also discuss how individualizing the treatment approach for each patient can play a crucial role in providing effective therapy for patients with medication-resistant illness. Readers may find it helpful to draw on their clinical experience in assessing which components of the approach described here are common to a variety of prevalent psychotherapeutic modalities and which are specific to cognitive therapy.
The author gratefully acknowledges Sylvia Nasar and Simon & Schuster for permission to reproduce ... more The author gratefully acknowledges Sylvia Nasar and Simon & Schuster for permission to reproduce excerpts from A Beautiful Mind in this column. *The movie version of A Beautiful Mind has been a big step forward in public education about schizophrenia. The audience can empathize with the internal experience of having schizophrenia. However, some of the details in the movie version of Nash's treatment differ from the written biography. In this article, I draw on the written account of Nash's treatment history in the biography. † My knowledge of Nash's diagnosis, symptoms, and treatment comes from the biography, not from interviewing Nash or his family or reviewing his medical records. Therefore, to be precise, my comments pertain to descriptions of events as depicted in A Beautiful Mind and should not be taken as specific comments on Nash's actual diagnosis or treatment plan.
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maint... more Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent. For more information, please refer to our Privacy Policy. ... Skip Navigation Links Home > ...
JAMA: The Journal of the American Medical Association, 1985
To the Editor.—Report of a Case.— A 26-year-old man with multiple hospitalizations for chemothera... more To the Editor.—Report of a Case.— A 26-year-old man with multiple hospitalizations for chemotherapy of stage IV lymphoma experienced a severe subjective sense of restlessness and anxiety. "I feel like jumping out of my skin.... I can't stand this hospital anymore." These complaints were considered to be secondary to his anxiety about his illness and prognosis. However, the restlessness was a distinct change from his behavior during previous hospitalizations and coincided with administration of prochlorperazine (Compazine), 10 mg intravenously every six hours, for nausea. A tentative diagnosis of drug-induced akathisia was made, prochlorperazine treatment was discontinued, and the restlessness completely abated within three days. Comment.— Extrapyramidal reactions can occur from dopamine blocking agents such as prochlorperazine or metoclopramide, which are commonly used as antiemetics.1However, it has been my experience as well as others'2that akathisia, an intense and highly distressing subjective sense of restlessness, is the side
Clinical Schizophrenia & Related Psychoses, 2010
Reflecting an increasing awareness of the importance of treatment adherence on outcomes in psychi... more Reflecting an increasing awareness of the importance of treatment adherence on outcomes in psychiatric populations, the National Institute of Mental Health (NIMH) convened a panel of treatment adherence researchers on September 27-28, 2007 to discuss and articulate potential solutions for dealing with methodological adherence research challenges. Panel discussions and presentations were augmented with targeted review of the literature on specific topics, with a focus on adherence to medication treatments in adults with serious mental illness. The group discussed three primary methodological areas: participants, measures, and interventions. When selecting patients for adherence-enhancing interventions (AEIs), a three-tier model was proposed that draws from the universal (targeting all patients receiving medication treatment for a specific condition, regardless of current adherence), selective (targeting patients at risk for nonadherence), and indicated (targeting patients who are currently nonadherent) prevention model and emphasizes careful patient characterization in relevant domains and appropriate matching of interventions to the selected population. Proposals were also made to reduce problematic selection biases in patient recruitment and retention. The panel addressed the pros and cons of various methods that can be used to measure adherence, and concluded that it is appropriate to use multiple measures whenever possible. Finally, the panel identified a broad range of intervention approaches, and conditions under which these interventions are likely to be most effective at reducing barriers to adherence and reinforcing adherence behavior.
Clinical Schizophrenia & Related Psychoses, 2014
Most first-episode schizophrenia patients will stop their medication after their acute symptoms i... more Most first-episode schizophrenia patients will stop their medication after their acute symptoms improve. Understanding the salient motivations and attitudes that drive adherence--as well as nonadherence--is an important part of developing strategies to prevent or delay nonadherence during the early phases of the illness. Self-reported reasons for adherence and nonadherence among first-episode and multi-episode patients with schizophrenia were obtained from cross-sectional adherence interviews from two prospective adherence studies: one composed of a first-episode sample (n=33) and the other with recently relapsing multi-episode patients (n=16). Both groups received the Rating of Medication Influences (ROMI) Scale at approximately 16 to 20 weeks after an acute psychotic episode. The specific ROMI items were ranked in order of percentage (%) strong, and were compared both within each patient group for rank order of importance, and also compared between groups to determine the differences in specific adherence and nonadherence influences. The doctor-patient relationship was more likely to be endorsed as a strong adherence influence in the first-episode sample (74%) than in the multi-episode sample (13%, X²=18.07, p<.01). Change in physical appearance attributed to medication was a more commonly endorsed nonadherence influence for the multi-episode sample (25%) relative to the first-episode sample (0%, X²=9.2, p<.01). The doctor-patient relationship stands out as being the major reason for ongoing adherence for first-episode schizophrenia patients. Our post hoc interpretation is that lack of prior experience with medication and treatment elevates the importance of the relationship with the treating clinician for first-episode patients.
An increased risk of developing TD has been associated with factors such as older age, female sex... more An increased risk of developing TD has been associated with factors such as older age, female sex, underlying mental illness, and long-term use and higher doses of antipsychotics. The association of TD with the use of typical versus atypical antipsychotics has also been evaluated, with mixed results. To date, predictive models assessing the joint effect of clinical characteristics on TD risk have not been developed and validated in the US population. STUDY OBJECTIVE: To develop a prediction model to identify patient and treatment characteristics associated with the occurrence of TD among patients with psychiatric disorders taking antipsychotic medications, using a retrospective database analysis. METHODS: Adult patients with schizophrenia, major depressive disorder, or bipolar disorder who were taking oral antipsychotics, and who had 6 months of data prior to the index date were identified from Medicaid claims from six US states. The index date was defined as the date of the first claim for an antipsychotic drug after a claim for the underlying disorder but before TD diagnosis. A multivariate Cox prediction model was developed using a cross-validated version of the least absolute shrinkage and selection operator (LASSO) regression method to improve prediction accuracy and interpretability of the model. The predictive performance was assessed in a separate validation set via model discrimination (concordance) and calibration. RESULTS: A total of 189,415 patients were identified: 66,723 with bipolar disorder, 68,573 with depressive disorder, and 54,119 with schizophrenia. The selected prediction model had a clinically meaningful concordance of 70% and was well calibrated (P = 0.46 for Hosmer-Leme show goodness-of-fit test). Patient's age at index date (hazard ratio [HR]: 1.03), diagnosis of schizophrenia (HR: 1.73), dosage of antipsychotic at index date (up to 100 mg/day chlorpromazine equivalent; HR: 1.40), and presence of bipolar and related disorders (HR: 1.16) were significantly associated with an increased risk of TD diagnosis. Use of atypical antipsychotics at index date was associated with a modest reduction in the risk of TD (HR = 0.94). CONCLUSIONS: This study identified a group of factors associated with the development of TD among patients with psychiatric disorders treated with antipsychotics. This may allow physicians to better monitor their patients receiving antipsychotics, allowing for the prompt identification and treatment of TD to help maintain quality of life.
To review the use of paliperidone palmitate in treatment of patients with schizophrenia. Methods:... more To review the use of paliperidone palmitate in treatment of patients with schizophrenia. Methods: Published clinical trial data for the development and utilization of paliperidone palmitate for the treatment of schizophrenia were assessed in this review. Four short-term, randomized, double-blind, placebo-controlled trials investigated the efficacy of paliperidone palmitate in acute exacerbation of schizophrenia. Paliperidone palmitate was also studied as a maintenance treatment to prevent or delay relapse in stable schizophrenia. In addition, paliperidone palmitate was compared to risperidone long-acting injection for noninferiority in three studies. Results: Paliperidone palmitate has been shown to be effective in reducing symptoms as measured by the Positive and Negative Syndrome Scale total scores in the four acute treatment studies. In the maintenance treatment studies, paliperidone palmitate was found to be more effective than placebo in preventing or delaying the time to first relapse in stable schizophrenia patients. In addition, paliperidone palmitate was shown to be noninferior to risperidone long-acting injection in two studies. It was shown to be reasonably well tolerated in all clinical trials. Acute treatment phase should be initiated with a dose of 234 mg on day one and 156 mg on day eight, followed by a recommended monthly maintenance dose of 39-234 mg based on efficacy and tolerability results from the clinical studies. Providing an optimal long-term treatment can be challenging. Paliperidone palmitate can be used as an acute treatment even in outpatient setting, and it has shown to be well tolerated by patients. Also, it does not require overlapping oral antipsychotic supplementation while being initiated, and is dosed once per month.
Background: A randomized, controlled, phase 3b study (ALPINE) evaluated efficacy and safety of a ... more Background: A randomized, controlled, phase 3b study (ALPINE) evaluated efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) using a 1-day initiation regimen in patients hospitalized for an acute exacerbation of schizophrenia. Paliperidone palmitate (PP) was used as an active control. Exploratory endpoint assessments included severity of illness, positive and negative symptoms, quality of life, caregiver burden, and satisfaction with medication. Methods: Adults were randomly assigned to AL 1064 mg q8wk or PP 156 mg q4wk as inpatients, discharged after 2 weeks, and followed through week 25. Exploratory efficacy measures included the 3 original PANSS subscales, Clinical Global Impression−Severity (CGI-S) subscale, and caregiver Burden Assessment Scale. Exploratory patientreported outcomes (PROs) included the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) and the Medication Satisfaction Questionnaire. Within-group changes from baseline through week 25 were analyzed for AL and PP separately. PROs were summarized based on observed data.
Payne Whitney Psychiatric Clinic in New York City. He is also a project psychiatrist on a Nationa... more Payne Whitney Psychiatric Clinic in New York City. He is also a project psychiatrist on a National Institute of Mental Health multicenter outpatient schizophrenia study and is conducting research on noncompliance and extrapyramidal disorders. The patient Ms. M, a 22-year-old single file clerk living with her parents, was admitted to an acute inpatient psychiatric unit with florid psychosis after rejection by a boyfriend. She presented with delusions of thought insertion and control from the spirit of her brother, who had died 15 years earlier, and the paranoid delusion that her food was poisoned by her father. For the week before admission, her parents refrained from seeking treatment for her despite her symptoms, but one night Ms. M left home, took the family car, and drove through the night to her brother's grave 300 miles away. On her return the next day, her parents brought her to the hospital, where she was admitted. Ms. M's parents reported that
... and should not be dismissed as an emo-tional disturbance (3). Psychotro-pic medications are e... more ... and should not be dismissed as an emo-tional disturbance (3). Psychotro-pic medications are etiologically implicated in the swallowing disor-ders of patients with Parkinson's disease and tadive dyskinesia by a variety ofpathophysiologic factors. First, dysphagia is present in ...
Few investigations have assessed the neuropsychological effects of psychotropic medications on sc... more Few investigations have assessed the neuropsychological effects of psychotropic medications on schizophrenic patients. In this study, 44 clinically stable schizophrenic inpatients were administered a battery of neuropsychological tests, and their performance was correlated with dosage of neuroleptic medication and benztropine. Neuroleptic dose was correlated with poorer performance on tests of psychomotor speed and attention, and with the number of perserverative errors on the Wisconsin Card Sort. Anticholinergic dose was associated with poorer verbal learning, verbal fluency, and motor speed. Both medication dosages were associated with poorer verbal recognition memory, but this association was strongly influenced by the performance of individuals on the highest medication doses. The findings, which were independent of clinical state and intelligence, indicate that higher doses of neuroleptic and anticholinergic medications are associated with poorer neuropsychological functioning in schizophrenia.
Nonadherence to antipsychotic medications in serious, persistent mental illness remains a signifi... more Nonadherence to antipsychotic medications in serious, persistent mental illness remains a significant clinical challenge. Long-acting therapy was developed to help improve adherence to schizophrenia therapy and provide an effective means for ameliorating symptoms and preventing relapse. The Agency for Health Care Policy and Research/National Institute of Mental Health Schizophrenia Patient Outcomes Research Team recommends that antipsychotic long-acting therapy be strongly considered for patients who have difficulty adhering to an oral medication regimen or who prefer long-acting therapy. Depot conventional formulations have long been available; for clinicians and patients who would rather use an atypical antipsychotic, studies with risperidone long-acting therapy suggest that it is efficacious and well tolerated. A common concern of clinicians who elect to initiate long-acting therapy is how to introduce the possibility of changing from the current oral antipsychotic to an long-act...
The objective of this study was to evaluate the relationship between compliance with an antipsych... more The objective of this study was to evaluate the relationship between compliance with an antipsychotic medication regimen and risk of hospitalization in a cohort of California Medicaid patients with schizophrenia. Methods: Compliance behavior was estimated by using a retrospective review of California Medicaid pharmacy refill and medical claims for 4,325 outpatients for whom antipsychotics were prescribed for treatment of schizophrenia from 1999 to 2001. Compliance behavior was estimated by using four different definitions: gaps in medication therapy, medication consistency and persistence, and a medication possession ratio. Patients were followed for one year and had an average of 19.1 dispensing events. Logistic regression models using each compliance estimate were used to determine the odds of hospitalization. Results: Risk of hospitalization was significantly correlated with compliance. With all definitions, lower compliance was associated with a greater risk of hospitalization over and above any other risk factors for hospitalization. For example, the presence of any gap in medication coverage was associated with increased risk of hospitalization, including gaps as small as one to ten days (odds ratio [OR]=1.98). A gap of 11 to 30 days was associated with an OR of 2.81, and a gap of more than 30 days was associated with an OR of 3.96. Conclusions: This study showed a direct correlation between estimated partial compliance and hospitalization risk among patients with schizophrenia across a continuum of compliance behavior. (Psychiatric Services 55:886-891, 2004)
In this column, the authors elaborate on how cognitive therapy can be adapted for patients with s... more In this column, the authors elaborate on how cognitive therapy can be adapted for patients with schizophrenia and discuss some considerations about the availability of cognitive therapy in the United Kingdom and the United States. Beneficial aspects of cognitive therapy for these patients include developing ongoing relationships with therapists who engage the patients in understanding their delusions and hallucinations and relating these experiences, which appear bizarre to others but are not recognized as such by the patient, to their real life experiences. This process may enable patients to gain perspective on their symptoms and employ the healthier parts of their thinking in managing their illness and their life circumstances. The authors also discuss how individualizing the treatment approach for each patient can play a crucial role in providing effective therapy for patients with medication-resistant illness. Readers may find it helpful to draw on their clinical experience in assessing which components of the approach described here are common to a variety of prevalent psychotherapeutic modalities and which are specific to cognitive therapy.
The author gratefully acknowledges Sylvia Nasar and Simon & Schuster for permission to reproduce ... more The author gratefully acknowledges Sylvia Nasar and Simon & Schuster for permission to reproduce excerpts from A Beautiful Mind in this column. *The movie version of A Beautiful Mind has been a big step forward in public education about schizophrenia. The audience can empathize with the internal experience of having schizophrenia. However, some of the details in the movie version of Nash's treatment differ from the written biography. In this article, I draw on the written account of Nash's treatment history in the biography. † My knowledge of Nash's diagnosis, symptoms, and treatment comes from the biography, not from interviewing Nash or his family or reviewing his medical records. Therefore, to be precise, my comments pertain to descriptions of events as depicted in A Beautiful Mind and should not be taken as specific comments on Nash's actual diagnosis or treatment plan.
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maint... more Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent. For more information, please refer to our Privacy Policy. ... Skip Navigation Links Home > ...
JAMA: The Journal of the American Medical Association, 1985
To the Editor.—Report of a Case.— A 26-year-old man with multiple hospitalizations for chemothera... more To the Editor.—Report of a Case.— A 26-year-old man with multiple hospitalizations for chemotherapy of stage IV lymphoma experienced a severe subjective sense of restlessness and anxiety. "I feel like jumping out of my skin.... I can't stand this hospital anymore." These complaints were considered to be secondary to his anxiety about his illness and prognosis. However, the restlessness was a distinct change from his behavior during previous hospitalizations and coincided with administration of prochlorperazine (Compazine), 10 mg intravenously every six hours, for nausea. A tentative diagnosis of drug-induced akathisia was made, prochlorperazine treatment was discontinued, and the restlessness completely abated within three days. Comment.— Extrapyramidal reactions can occur from dopamine blocking agents such as prochlorperazine or metoclopramide, which are commonly used as antiemetics.1However, it has been my experience as well as others'2that akathisia, an intense and highly distressing subjective sense of restlessness, is the side
Clinical Schizophrenia & Related Psychoses, 2010
Reflecting an increasing awareness of the importance of treatment adherence on outcomes in psychi... more Reflecting an increasing awareness of the importance of treatment adherence on outcomes in psychiatric populations, the National Institute of Mental Health (NIMH) convened a panel of treatment adherence researchers on September 27-28, 2007 to discuss and articulate potential solutions for dealing with methodological adherence research challenges. Panel discussions and presentations were augmented with targeted review of the literature on specific topics, with a focus on adherence to medication treatments in adults with serious mental illness. The group discussed three primary methodological areas: participants, measures, and interventions. When selecting patients for adherence-enhancing interventions (AEIs), a three-tier model was proposed that draws from the universal (targeting all patients receiving medication treatment for a specific condition, regardless of current adherence), selective (targeting patients at risk for nonadherence), and indicated (targeting patients who are currently nonadherent) prevention model and emphasizes careful patient characterization in relevant domains and appropriate matching of interventions to the selected population. Proposals were also made to reduce problematic selection biases in patient recruitment and retention. The panel addressed the pros and cons of various methods that can be used to measure adherence, and concluded that it is appropriate to use multiple measures whenever possible. Finally, the panel identified a broad range of intervention approaches, and conditions under which these interventions are likely to be most effective at reducing barriers to adherence and reinforcing adherence behavior.
Clinical Schizophrenia & Related Psychoses, 2014
Most first-episode schizophrenia patients will stop their medication after their acute symptoms i... more Most first-episode schizophrenia patients will stop their medication after their acute symptoms improve. Understanding the salient motivations and attitudes that drive adherence--as well as nonadherence--is an important part of developing strategies to prevent or delay nonadherence during the early phases of the illness. Self-reported reasons for adherence and nonadherence among first-episode and multi-episode patients with schizophrenia were obtained from cross-sectional adherence interviews from two prospective adherence studies: one composed of a first-episode sample (n=33) and the other with recently relapsing multi-episode patients (n=16). Both groups received the Rating of Medication Influences (ROMI) Scale at approximately 16 to 20 weeks after an acute psychotic episode. The specific ROMI items were ranked in order of percentage (%) strong, and were compared both within each patient group for rank order of importance, and also compared between groups to determine the differences in specific adherence and nonadherence influences. The doctor-patient relationship was more likely to be endorsed as a strong adherence influence in the first-episode sample (74%) than in the multi-episode sample (13%, X²=18.07, p<.01). Change in physical appearance attributed to medication was a more commonly endorsed nonadherence influence for the multi-episode sample (25%) relative to the first-episode sample (0%, X²=9.2, p<.01). The doctor-patient relationship stands out as being the major reason for ongoing adherence for first-episode schizophrenia patients. Our post hoc interpretation is that lack of prior experience with medication and treatment elevates the importance of the relationship with the treating clinician for first-episode patients.
An increased risk of developing TD has been associated with factors such as older age, female sex... more An increased risk of developing TD has been associated with factors such as older age, female sex, underlying mental illness, and long-term use and higher doses of antipsychotics. The association of TD with the use of typical versus atypical antipsychotics has also been evaluated, with mixed results. To date, predictive models assessing the joint effect of clinical characteristics on TD risk have not been developed and validated in the US population. STUDY OBJECTIVE: To develop a prediction model to identify patient and treatment characteristics associated with the occurrence of TD among patients with psychiatric disorders taking antipsychotic medications, using a retrospective database analysis. METHODS: Adult patients with schizophrenia, major depressive disorder, or bipolar disorder who were taking oral antipsychotics, and who had 6 months of data prior to the index date were identified from Medicaid claims from six US states. The index date was defined as the date of the first claim for an antipsychotic drug after a claim for the underlying disorder but before TD diagnosis. A multivariate Cox prediction model was developed using a cross-validated version of the least absolute shrinkage and selection operator (LASSO) regression method to improve prediction accuracy and interpretability of the model. The predictive performance was assessed in a separate validation set via model discrimination (concordance) and calibration. RESULTS: A total of 189,415 patients were identified: 66,723 with bipolar disorder, 68,573 with depressive disorder, and 54,119 with schizophrenia. The selected prediction model had a clinically meaningful concordance of 70% and was well calibrated (P = 0.46 for Hosmer-Leme show goodness-of-fit test). Patient's age at index date (hazard ratio [HR]: 1.03), diagnosis of schizophrenia (HR: 1.73), dosage of antipsychotic at index date (up to 100 mg/day chlorpromazine equivalent; HR: 1.40), and presence of bipolar and related disorders (HR: 1.16) were significantly associated with an increased risk of TD diagnosis. Use of atypical antipsychotics at index date was associated with a modest reduction in the risk of TD (HR = 0.94). CONCLUSIONS: This study identified a group of factors associated with the development of TD among patients with psychiatric disorders treated with antipsychotics. This may allow physicians to better monitor their patients receiving antipsychotics, allowing for the prompt identification and treatment of TD to help maintain quality of life.
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