Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

This study has been completed.
Sponsor:
Information provided by:
China Medical University, China
ClinicalTrials.gov Identifier:
NCT01303601
First received: February 24, 2011
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Bipolar Disorder
Depression, Bipolar
Drug: olanzapine
Drug: Starch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response [ Time Frame: once ] [ Designated as safety issue: No ]
  • The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission [ Time Frame: once ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity of Illness Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Improvement Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2009
Study Completion Date: October 2010
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303601

Locations
China, Liaoning
Department of Psychiatry, the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
Study Director: Man Wang, M.D. China Medical University, China
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01303601     History of Changes
Other Study ID Numbers: MWang
Study First Received: February 24, 2011
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by China Medical University, China:
Olanzapine
Monotherapy
bipolar Ⅰ depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 30, 2014