A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
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ClinicalTrials.gov Identifier: NCT01193153 |
Recruitment Status :
Completed
First Posted : September 1, 2010
Results First Posted : January 5, 2015
Last Update Posted : January 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizoaffective Disorder | Drug: Placebo Drug: paliperidone palmitate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 667 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
paliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months
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Drug: paliperidone palmitate
78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months |
Placebo Comparator: 002
Placebo monthly by i.m. injection for 15 months
|
Drug: Placebo
monthly by i.m. injection for 15 months |
- Double-blind: Percentage of Participants Who Experienced Relapse [ Time Frame: Day 1 up to Month 15 of double blind relapse prevention period ]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.
- 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]) [ Time Frame: Baseline and Week 64 of double blind relapse prevention period ]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.
- Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period ]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.
- Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period ]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.
- Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in DB period ]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.
- Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period ]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.
- Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period ]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.
- Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period ]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.
- Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period ]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.
- Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period ]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.
- Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period ]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.
- Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period ]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".
- Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint [ Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period ]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".

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193153

Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
Responsible Party: | Janssen Scientific Affairs, LLC |
ClinicalTrials.gov Identifier: | NCT01193153 |
Other Study ID Numbers: |
CR016618 R092670SCA3004 ( Other Identifier: Janssen Scientific Affairs, LLC ) |
First Posted: | September 1, 2010 Key Record Dates |
Results First Posted: | January 5, 2015 |
Last Update Posted: | January 5, 2015 |
Last Verified: | December 2014 |
schizoaffective disorder paliperidone palmitate INVEGA SUSTENNA schizoaffective disorder relapse prevention |
Disease Recurrence Psychotic Disorders Pathologic Processes Disease Attributes Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Paliperidone Palmitate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents |