major depressive episode of bipolar disorder
Conditions
Interventions
combination therapy of olanzapine and escitalopram for 8 weeks (the period can be extended up to 24 weeks if there is the efficacy without serious adverse events)
Sponsors
Department of Psychiatry, Hokkaido University Hospital
Kawamura Mental Clinic Sapporo City Hospital Ishikane Hosipital Sapporo Suzuki Hospital Sapporo Hanazono Hospital Tomakomai Midorigaoka Hospital Honda Memorial Hospital Maki Hosipital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female subjects between the ages of 20 and 65 years -subjects meeting diagnostic criteria of The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR for bipolar I disorder or bipolar II disorder, most recent episode depressed. -subjects who show the poor response to the previous treatment and meet the following criteria - MADRS total scores: more than 19 - YMRS total scores: less than 5 - subjects who receive the same treatment for the last 4 weeks and have the records of medication history in past 4 weeks -subjects who sign the informed consent document
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness, improvements in depressive symptoms as measured by the mean change in MADRS total scores from baseline to weeks 8 and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasuya Nakato
Hokkaido University Hospital Department of Psychiatry
Outcome results
None listed