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Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303601
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Information provided by:
China Medical University, China

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression, Bipolar Drug: olanzapine Drug: Starch Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study
Study Start Date : January 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: olanzapine Drug: olanzapine

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

Placebo Comparator: placebo Drug: Starch

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: once weekly ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303601

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China, Liaoning
Department of Psychiatry, the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
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Study Director: Man Wang, M.D. First Hospital of China Medical University
Layout table for additonal information Identifier: NCT01303601    
Other Study ID Numbers: MWang
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: December 2008
Keywords provided by China Medical University, China:
bipolar Ⅰ depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents