Optimal Duration of Olanzapine Add-on Therapy in Major Depression
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapse Rate of a Major Depressive Episode; Safety of Olanzapine in Subjects With Major Depression
Intervention: Olanzapine (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Ion Anghelescu, MD, Principal Investigator, Affiliation: Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
Arnim Quante, MD, Principal Investigator, Affiliation: Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
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.
Clinical Details
Official title: Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-Controlled, Randomized, Phase III, Pilot Study in Parallel Group Design
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relapse Rate, Hamilton Depression Rating Scale (17 item version)
Secondary outcome: Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin, Berlin 14050, Germany
Additional Information
Starting date: October 2007
Ending date: April 2008
Last updated: April 23, 2008
|
