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NCT Number: NCT01303601

Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depression, Bipolar Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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

Starch

Drug

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale

    Time frame: once weekly

Secondary outcomes

  1. The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response

    Time frame: once

  2. The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission

    Time frame: once

  3. Young Mania Rating Scale

    Time frame: once weekly

  4. Clinical Global Impressions-Severity of Illness Scale

    Time frame: once weekly

  5. Clinical Global Impressions-Improvement Scale

    Time frame: once weekly

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study

Important dates

Study start
2009
Study completion
2010
First posted
Feb 25, 2011
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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