Status:
WITHDRAWN
Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial
Lead Sponsor:
University Hospital Freiburg
Conditions:
Therapy-resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
60 patients with major depression will be treated with 10 mg Olanzapine or Placebo for 2 weeks. In case of response (reduction of depressive symptoms)the study will be continued for further 60 days.
Detailed Description
The study is using a randomized double-blind, parallel-group, placebo-controlled design. 30 patients per treatment group will be included into the study and randomized to the treatment groups using a ...
Eligibility Criteria
Inclusion
- major depression without psychotic features
- therapy resistance (2 courses of antidepressants from different classes for more than 3 weeks in adequate dose
- HAM-D score greater/equal than 17
- age 18-65
Exclusion
- bipolar disorder
- active alcohol or illicit drug use
- female with ineffective contraception
- severe medical conditions, epilepsy
- psychotic features
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00273624
Start Date
June 1 2005
End Date
December 1 2009
Last Update
August 10 2022
Active Locations (1)
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1
Dept. of Psychiatry, University of Freiburg
Freiburg im Breisgau, Germany, 79104