Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

China Medical University, China

Status and phase: Completed; Phase 4

Conditions: Depression, Bipolar; Bipolar Disorder

Treatments: Drug: Starch; Drug: olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01303601

MWang

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

olanzapine

Experimental group

Treatment:

Drug: olanzapine

placebo

Placebo Comparator group

Treatment:

Drug: Starch