EUCTR2006-001490-15-DE进行中（未招募）不适用
A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for theprevention of mood episodes in the treatment of subjects with bipolar I disorder
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects may be male or female and must be between the ages of 18 and 65 years, inclusive.
- •Subjects must have a diagnosis of bipolar I disorder as defined by
- •DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Subjects who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder or generalized anxiety disorder are acceptable. All other comorbid or active Axis I diagnoses are excluded. Personality disorders as defined by DSM IV TR criteria are acceptable, with the exception of antisocial and borderline personality disorders.
- •Subjects must be currently experiencing a manic or mixed episode (YMRS >20 and CGI-S ³4 [moderate]) or must be between mood episodes (non-acute; YMRS <12 and CGI-S £3 [mild]).
- •Subjects must have had at least 2 bipolar mood (manic, mixed manic, or depressed) episodes, exclusive of the current episode (if applicable), during the last year. For non-acute subjects (YMRS <12 and CGI-S £3 [mild]), one manic episode must have occurred within 4 months of enrollment.
- •Subjects who are non-acute (YMRS <12 and CGI-S £3 [mild]) and are currently receiving an antipsychotic other than risperidone or a mood stabilizer must have received this other medication at the same dosage for a minimum of 4 weeks and must be either experiencing problems of safety or tolerability with the antipsychotic or mood stabilizer or request a change of medication.
- •Only inpatients who are voluntary inpatients at the time of screening, once informed consent is obtained, may be included in the study.
- •Outpatients must not be a danger to themselves or others, and must have sufficient medical monitoring and family support available to be maintained as outpatients. The outpatient status may include partial care or day hospital care, or other forms of outpatient care while the subject resides with his or her family or similar home care providers.
- •Subjects with a history of ADHD, anxiety disorder, or panic disorder are acceptable if this is not the primary diagnosis.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Having a history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
- •Having received an experimental drug or used an experimental medical device within 30 days prior to screening.
- •Having a history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis.
- •Meeting DSM-IV-TR criteria for a hypomanic or depressive episode.
- •Meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria.
- •Meeting DSM-IV-TR criteria for antisocial or borderline personality disorder.
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A randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for theprevention of mood episodes in the treatment of subjects with bipolar I disorderEUCTR2006-001490-15-GRJanssen-Cilag International N.V720
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