Status:
COMPLETED
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 to...
Detailed Description
Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To date however, no medication has been evaluated in the maintenance treatment of schizoaffective disorder. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT01193153
Start Date
September 1 2010
End Date
October 1 2013
Last Update
January 5 2015
Active Locations (80)
Enter a location and click search to find clinical trials sorted by distance.
1
Garden Grove, California, United States
2
Oakland, California, United States
3
Oceanside, California, United States
4
Pico Rivera, California, United States