Olanzapine augmentation therapy in treatment-resistent depression: a double-blind placebo-controlled trial

Phase 3

Recruiting

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00000021
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

major depression without psychotic features (DSM-IV definition)
- therapy resistance (two courses of antidepressant from different classes > 3 weeks in adequate dose), HAM-D more or equal 17
- age: 18-65

Exclusion Criteria

- bipolar disorder
- active alcohol or illicit drug use
- female without effective contraception
- severe medical conditions, epilepsy
- psychotic features ( P1, P3 an P6 more or equal 2 at inclusion)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A responder is defined by a reduction of the initial HAM-D score of more than 50 %.