Bipolar disorder Mental and Behavioural Disorders Bipolar disorder
Conditions
Interventions
Patients will be randomised to one of three groups:
1. '0' week group: patients will receive lithium or valproate plus placebo for 52 weeks (risperidone or olanzapine tapering will begin on the day of
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to any mood episode. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to premature discontinuation from the study for any clinical reason (dose change in medication, new intervention, side effects, etc.) 2. Time to manic episode 3. Time to depressive episode 4. Proportion of patients gaining more than 7% of body weight (this amount of weight gain is significant for cardiovascular morbidity) 5. Proportion of patients developing extrapyramidal symptoms, tardive dyskinesia, prolactin related side effects 6. Changes in YMRS, HAM-D 21, CGI-S, ESRS scores and weight during the study period | — |
Countries
Canada
Outcome results
None listed