Atypical antipsychotics for continuation and maintenance treatment after an acute manic episode: a randomised controlled trial

niversity of British Columbia (Canada)0 个研究点目标入组 540 人开始时间: 2005年9月1日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients who were recently (within the last 12 weeks) commenced on treatment for a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) manic or mixed episode with a combination of lithium and risperidone, lithium and olanzapine, valproate and risperidone, or valproate and olanzapine
•2. Patients who are in remission from mania for at least 2 weeks but no more than 6 weeks. Remission is defined as either:
•2.1. A Clinical Global Impression - Severity (CGI-S) scale score of 2 (borderline mentally ill) or less (normal, not ill) for 2 consecutive weeks
•2.2. A YMRS score of 8 or less (normal range) and a Hamilton Rating Scale for Depression (HAM-D) 21-item score of 8 or less (normal range) for 2 consecutive weeks
•3. Must not be taking any other psychotropic medication with the exception of benzodiazepines (maximum of lorazepam 4 mg per day or its equivalent)
•4. Patients aged 18 and above (efficacy of risperidone and olanzapine is not tested in those below 18 years of age), either sex
•5. Patients on 1 to 6 mg risperidone or 5 to 25 mg olanzapine (these are the dose ranges commonly used in clinical practice, and are shown to be effective doses in acute mania trials)

•As we want the findings to be generalisable to clinically representative patients with bipolar disorder, we will not exclude any patients with a history of co-morbid substance abuse or medical illnesses. Any subjects who do not meet the above inclusion criteria will be excluded from the study.

发起方

niversity of British Columbia (Canada)