PER-006-05已完成未知
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.
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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