Optimal Duration of Olazapine Add-on therapy in Major Depression: A double-blind, placebo-controlled, randomized, Phase III, Pilot Study in parallel group Design - OLA-D

Conditions: Major Depression

Registration Number: EUCTR2007-000512-82-DE

Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-informed consent of patient
-age 18 - 80 yrs.
-diagnosis of major depression according to DSM-IV, unipolar course
-Hamilton-Depression-Scale (17 item score) >18 prior to inclusion
-response towards therapy with antidepressant and Olanzapine as defined by >50% reduction of HAM-D (17) score
-negative pregnancy testing
-highly effective contraceptive method in women (Pearl-index<1) or sexual abstinence during study period
-no participation in any other trial according to German Pharmaceuticals Act (AMG)1month prior to and during study participation
-normal liver function (SGOT, SGPT)(see exclusion criteria)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-duration of current depressive episode > 1yr.
-number of previous episodes > 5
-pregnancy, lactation
-depressive episode secondary to somatic disease or substance dependency
-contraindication for Zyprexa substance or constituents
-severe psychotic symptoms and/or hallucinations (PANSS positive scale: 4 or more on one of the following items: delusions P1, hallucinations P3, Delusions of persecution P6)
-treatment with interacting substances (CYP1A2 inhibitors or inductors)
-treatment with substances prolonging QTc period as listed in the protocol appendix
-comorbidity according to DSM-IV, axis I
-denial of consent to §12, §13 GCP-V (Germany)
-hospital treatment by legal order
-hepatic insufficiency, elevation of SGOT, SGPT, and/or GGT of more than 3fold upper reference value
-severe neurological or medical disease
-adipositas permagna (BMI>30)
-HIV-infection
-active viral hepatitis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Hypothesis: In major depression, long-term add-on treatment with Olanzapine prevents relapse more effectively than treatment with antidepressants alone.<br>Primary endpoint is the relapse rate after response and remission as rated with the Hamilton-Depression Scale (HAM-D-17);Secondary Objective: Secondary endpoints are tolerability and safety of Olanzapine in long-term treatment, long-term efficacy of Olanzapine in major depression with additional mild psychotic features, determination of necessary co-medication, rehospitalisation rate, quality of life, as measured with self-rating scales (SWN: Subjective Wellbeing Under Neuroleptics) and CGI (Clinical Global Impression);Primary end point(s): -relapse rate after response or remission

Secondary Outcome Measures