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

niversity of British Columbia (Canada)0 sites540 target enrollmentSeptember 1, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 1, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of British Columbia (Canada)

•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.