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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT01193153

Run by

Janssen Scientific Affairs, LLC

People needed

667

Starts

2010-09-01

Expected to finish

2013-10-01

Last updated by the study team

2015-01-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hollywood, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Schamburg, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Flowood, Mississippi, United States
• Study site — Creve Coeur, Missouri, United States
• Study site — Cedarhurst, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Arlington, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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