Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizoaffective Disorder, Psychotic Disorder

In brief

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Key facts

Study ID

NCT00412373

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

307

Starts

2006-12-01

Expected to finish

2008-06-01

Last updated by the study team

2014-05-09

Who can join

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

You may qualify if…

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
• A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60
• A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

You may not qualify if…

• A primary active mental illness diagnosis other than schizoaffective disorder
• Patients with first episode psychosis
• Active substance dependence within previous 6 months
• Treatment with clozapine within 6 months of randomization
• A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
• Pregnancy, breast-feeding, or planning to become pregnant

Where it is running

• Study site — Cerritos, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Garden Grove, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Pico Rivera, California, United States
• Study site — San Diego, California, United States
• Study site — Aventura, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Ahmedabad, India
• Study site — Ahmedibad, India
• Study site — Aurangabad, India
• Study site — Chennai, India
• Study site — Delhi, India
• Study site — Kanpur Uttarpradeh, India
• Study site — Pune, India
• Study site — Vadadora, India
• Study site — Ipoh, Malaysia
• Study site — Kota Kinabalu, Malaysia

Full record on ClinicalTrials.gov

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