A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Recruiting in Palo Alto (17 mi)
+83 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Janssen Scientific Affairs, LLC
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
JS
Janssen Scientific Affairs, LLC Clinical Trial
Principal Investigator
Janssen Scientific Affairs, LLC
Eligibility Criteria
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)
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Treatment Details
Interventions
- Paliperidone Palmitate (Antipsychotic)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 001Experimental Treatment1 Intervention
paliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months
Group II: 002Placebo Group1 Intervention
Placebo monthly by i.m. injection for 15 months
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Who Is Running the Clinical Trial?
Janssen Scientific Affairs, LLC
Lead Sponsor
Trials
165
Recruited
579,000+
Ricardo Attar
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology, University of Buenos Aires
Dr. Anastasia G. Daifotis
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2023
MD