Efficacy of Aripiprazole in Combination with Valproate or Lithium in the Treatment of Mania in Patients with Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
- Conditions
- -F31F31
- Registration Number
- PER-006-05
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
11) Patients diagnosed with substance abuse within the last 3 months.
12) Patients with thyroid disease.
13) Patients who have a history or evidence of a medical condition that would expose them to the undue risk of a significant adverse event
14) Patients with epilepsy or a history of seizures
15) Patients who test positive in the pharmacological analysis for cocaine.
16) Patients with significant abnormal results in laboratory tests, vital signs or ECG findings
17) Patients who have a CPK> 550 U / L must be approved before randomization.
18) Patients allergic, intolerant or that did not respond to previous treatments for mania in which haloperidol was used.
19) Patients with a history of hypersensitivity to antipsychotic agents.
20) Patients with a history of neuroleptic malignant syndrome
21) Patients who are using mood stabilizers
22) Patients who have received antidepressants within the previous two weeks
23) Patients likely to require concomitant therapy prohibited during the study
24) The recent treatment of his most recent manic or mixed acute episode with a long-acting antipsychotic.
25) Patients who have participated in a clinical trial with an agent in investigation within the last month or that has ever participated in a clinical trial with aripiprazole
26) Patients who probably need intensive individual psychotherapy
27) Management with electroconvulsive therapy in the last 3 months
28) In this study prisoners or individuals who are forcibly detained should not be enrolled.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Average change from the baseline to Week 3 (LOCF) on the Total Score of the Y-MRS.<br><br>Measure:Efficacy of therapy with Aripiprazole.<br>Timepoints:Before treatment (basal) and in week 3.<br>
- Secondary Outcome Measures
Name Time Method