PER-006-05
Completed
未知
Double-blind, randomized, multicenter, placebo-controlled study of monotherapy with Aripiprazole for the treatment of individuals with acute manic episodes associated with bipolar I disorder.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients who can provide informed consent and / or consent obtained from a legally acceptable representative
- •2\) Patients with Bipolar I Disorder associated with manic or mixed episode
- •3\) Patients who have a history of at least 1 manic episode or mixed
- •4\) Patients with a Total Score in the Y\-MRS\> 20 in the selection and at the end of Phase 1 (baseline)
- •5\) Patients with a Total Score in MADRS \<17 ai end of Phase 1 (baseline)
- •6\) Patients who can understand the nature of the study and follow the protocol requirements.
- •7\) Men and women in ages\> 18 years.
Exclusion Criteria
- •1\) Women of childbearing age who do not wish or can not use an acceptable method to avoid pregnancy during the entire study.
- •2\) Women of childbearing age who use a prohibited method of contraception
- •3\) Women who are pregnant or breastfeeding
- •4\) Women with positive results in the pregnancy test.
- •5\) Patients who present and / or have a history that is compatible with other psychiatric illnesses
- •6\) Patients with current diagnosis of Bipolar II Disorder
- •7\) Patients who experience their first manic or mixed episode.
- •8\) Patients considered refractory for the treatment of manic symptoms.
- •9\) Patients who have been hospitalized for\> 3 weeks for the current manic or mixed episode.
- •10\) Patients with significant risk of committing suicide
Outcomes
Primary Outcomes
Not specified
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