Schizoaffective Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Status | Completed |
Enrollment | 667 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - DSM-IV diagnosis of schizoaffective disorder - Experiencing an acute exacerbation of psychotic symptoms - A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14) - A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21 - Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements Exclusion Criteria: - A primary active mental illness diagnosis other than schizoaffective disorder - Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior - Subjects with first episode of psychosis - Received electroconvulsive therapy in the past 3 months - History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo) - Received long-acting antipsychotic medication within 2 injection cycles - Received therapy with clozapine within 3 months - A history of neuroleptic malignant syndrome - Previous history of lack of response to antipsychotic medication - Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening - Receiving therapy with carbamazepine - Receiving therapy with monoamine oxidase inhibitors - Pregnant, breast-feeding, or planning to become pregnant |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Scientific Affairs, LLC |
United States, Bulgaria, India, Malaysia, Philippines, Romania, South Africa, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Double-blind: Percentage of Participants Who Experienced Relapse | Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined. | Day 1 up to Month 15 of double blind relapse prevention period | No |
Secondary | Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA]) | The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision. | Baseline and Week 64 of double blind relapse prevention period | No |
Secondary | Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision. | Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | No |
Secondary | Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision. | Baseline and Endpoint (Week 64/LOCF) in double-blind period | No |
Secondary | Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores | The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed. | Baseline and Endpoint (Week 64/LOCF) in DB period | No |
Secondary | Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | No |
Secondary | Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | Baseline and Endpoint (Week 64/LOCF) in double-blind period | No |
Secondary | Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | No |
Secondary | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63. | Baseline and Endpoint (Week 64/LOCF) in double-blind period | No |
Secondary | Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | No |
Secondary | Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60. | Baseline and Endpoint (Week 64/LOCF) in double-blind period | No |
Secondary | Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit". | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | No |
Secondary | Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit". | Baseline and Endpoint (Week 64/LOCF) in double-blind period | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT01878513 -
Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Not yet recruiting |
NCT04551027 -
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
|
N/A | |
Completed |
NCT02901587 -
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
|
Phase 1 | |
Terminated |
NCT02796144 -
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
|
Phase 4 | |
Completed |
NCT02160249 -
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
|
N/A | |
Recruiting |
NCT02986490 -
Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs
|
N/A | |
Completed |
NCT02091388 -
Bioavailability of LY03004 and Risperdal® Consta®
|
Phase 1 | |
Terminated |
NCT02234752 -
Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia
|
Phase 2 | |
Completed |
NCT02417142 -
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
|
Phase 4 | |
Completed |
NCT01945333 -
Personalized and Scalable Cognitive Remediation Approaches
|
N/A | |
Terminated |
NCT02149823 -
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
|
Phase 1 | |
Completed |
NCT01975584 -
Neuroendocrine and Immune Response to Stress in Schizophrenia
|
N/A | |
Completed |
NCT01992393 -
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
|
N/A | |
Completed |
NCT01658150 -
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
|
N/A | |
Completed |
NCT01683539 -
Understanding How Cognitive Remediation Works
|
N/A | |
Completed |
NCT01198353 -
Effectiveness of Ziprasidone for Patients With Schizophrenia
|
Phase 4 |