Optimal Duration of Olanzapine Add-on Therapy in Major Depression
Phase 3
Withdrawn
- Conditions
- Relapse Rate of a Major Depressive EpisodeSafety of Olanzapine in Subjects With Major Depression
- Interventions
- Registration Number
- NCT00568672
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- informed consent
- age 18 - 80
- diagnosis of major depression according dsm-iv, unipolar course
- Hamilton-Depression-Rating-Scale (17 item score) > 18 prior to inclusion
- response towards therapy with antidepressant and olanzapine as defined > 50 % reduction of HAMDD score
- negative pregancy test
- highly effective contraceptive method in women
- no participation in other trial according to German Drug Laq
- normal liver function
Exclusion Criteria
- pregnancy, lactation
- depressive episode secondary to somatic disease or substance dependency
- contraindication for olanzapine
- treatment with interacting substances (CYP1A2 inhibitors or inductors)
- comorbidity according to DSM-IV, axis I
- denail of consent
- hospital treatment by legal order
- hepatic insufficiency
- severe neurological or medical disease
- adipositas permagna
- HIV-infection
- active viral hapatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Olanzapine Olanzapine 5 mg / day 2 Olanzapine Placebo
- Primary Outcome Measures
Name Time Method Relapse Rate, Hamilton Depression Rating Scale (17 item version) 6 months
- Secondary Outcome Measures
Name Time Method Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory 6 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which olanzapine modulates serotonin and dopamine receptors in major depression continuation therapy?
How does olanzapine add-on therapy compare to standard-of-care antidepressants in preventing relapse of major depressive episodes?
Which biomarkers correlate with sustained response to olanzapine augmentation in treatment-resistant depression?
What adverse metabolic and neurological events are associated with long-term olanzapine use in major depression patients?
Are there alternative antipsychotic-antidepressant combinations with better efficacy profiles than olanzapine in preventing depressive relapse?
Trial Locations
- Locations (1)
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin🇩🇪Berlin, Germany