Bipolar Disorder, Depression, Bipolar
Conditions
Keywords
Olanzapine, Monotherapy, bipolar Ⅰ depression
Brief summary
Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. The investigators conducted a randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for treatment of the depressed phase of bipolar disorder.
Detailed description
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.68 patients were randomized to assigned 6 weeks by olanzapine or placebo. Medications were provided in double-blind fashion. The assessments include Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, clinical Global Impressions-Severity of Illness scale, Clinical Global Impressions-Improvement scale, response and remission rates, and Treatment Emergent Symptom Scale.
Interventions
DRUGolanzapine
Tablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated. daily 6 weeks
DRUGStarch
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients with clinical diagnosis of bipolarⅠdisorder * MADRS total score ≥ 20 * CGI-S rating ≥ 4 * Normal results of physical examinations, laboratory and electrocardiogram tests * Being taken care of by a guardians during the trial
Exclusion criteria
* Pregnant or lactating women * YMRS total score ≥ 15 * Treatment with olanzapine within 3 months prior to study entry * Retrospective history of poor antidepressive response to or intolerance of olanzapine * Mental retardation * Addictive disorder * Diabetes mellitus * Dyslipidaemia * Cardiovascular diseases * Hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale | once weekly |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response | once |
| The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission | once |
| Young Mania Rating Scale | once weekly |
| Clinical Global Impressions-Severity of Illness Scale | once weekly |
| Clinical Global Impressions-Improvement Scale | once weekly |
Countries
China
Outcome results
None listed