JPRN-UMIN000014204
Completed
未知
A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japan - OLE-BD study
Department of Psychiatry, Hokkaido University Hospital0 sites60 target enrollmentJune 8, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- major depressive episode of bipolar disorder
- Sponsor
- Department of Psychiatry, Hokkaido University Hospital
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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