A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Paliperidone Palmitate

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)

• 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