A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japa

Not Applicable

• Conditions: major depressive episode of bipolar disorder

• Registration Number: JPRN-UMIN000014204
• Lead Sponsor: Department of Psychiatry, Hokkaido University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-08
• Study Completion: 2017-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

-subjects who have participated in a clinical trial of another investigational drug within 30 days before study entry -subjects who have a serious, unstable illness or an organic brain disease -subjects who are actively suicidal (Suicidal ideation score of MADRS is more than 3) or are judged clinically to be at serious suicidal risk by the investigator. -subjects who have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, personality disorders or substance-related disorders according to DSM-IV-TR -subjects who are contraindicated for use with olanzapine and escitalopram (eg. Having a history or diagnosis of diabetes mellitus) -subjects who have currently (within 2 months) received electoconvulsive therapy (ECT) -subjects who have received the combination therapy of olanzapine and escitalopram -women who are pregnant or provide breast feeding, or may be pregnant -subjects who are judged by the investigator to should be excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effectiveness, improvements in depressive symptoms as measured by the mean change in MADRS total scores from baseline to weeks 8 and 24.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of this study are to assess the combination of olanzapine and escitalopram in terms of; -changes in scores of the Clinical Global Impressions-Bipolar Version Severity of Illness (CGI-BP-S) from baseline to weeks 8 and 24. -improvement of subjective depressive symptoms, based on changes from baseline to weeks 8 and 24 in scores of Quick Inventory Depressive Symptomatology-Self Report, Japanese version: QIDS-SRJ). -remission rate of depression, with remission defined as a score =<9 in the MARDS total score or a score =<5 in the QIDS-SRJ total score. -emergence of mania, defined as a score >=12 in the YMRS total score and with >= 2 manic symptoms. -change in body weight, glucose and lipid metabolism, ECG, adverse reaction