A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

Key facts

Study ID

NCT00132678

Run by

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

People needed

559

Starts

2005-02-01

Expected to finish

2007-12-01

Last updated by the study team

2013-07-29

Who can join

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

You may qualify if…

• Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
• Two or more bipolar mood episodes in the last 2 years excluding current episode
• Negative pregnancy test

You may not qualify if…

• History of > than 4 mood episodes a year during the last two years
• patients experiencing a depressive episode
• History of antisocial or borderline personality illness
• Has unstable or serious general medical illness
• Has received medications disallowed by study criteria.

Where it is running

• Study site — La Mesa, California, United States
• Study site — National City, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Towson, Maryland, United States
• Study site — Clementon, New Jersey, United States
• Study site — Lyndhurst, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — DeSoto, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Neunkirchen, Austria
• Study site — Bangalore, India
• Study site — Hyderabad, India
• Study site — Manipal, India
• Study site — Johor Bahru, Malaysia
• Study site — Kota Bharu, Malaysia
• Study site — Kuala Lumpur, Malaysia
• Study site — Choroszcz, Poland
• Study site — Gdansk, Poland
• Study site — Swiecie Poland, Poland
• Study site — Tuszyn, Poland
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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