Optimal Duration of Olanzapine Add-on Therapy in Major Depression - Full Text View

Optimal Duration of Olanzapine Add-on Therapy in Major Depression (OLA-D)

This study has been withdrawn prior to enrollment.

( Withdrawn because of personal ressources before inclusion of the first patient )

First Received on December 5, 2007. Last Updated on April 23, 2008 History of Changes

Sponsor:	Charite University, Berlin, Germany
Collaborator:	Eli Lilly and Company
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00568672

Purpose

Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.

Condition	Intervention	Phase
Relapse Rate of a Major Depressive Episode Safety of Olanzapine in Subjects With Major Depression	Drug: Olanzapine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-Controlled, Randomized, Phase III, Pilot Study in Parallel Group Design

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Relapse Rate, Hamilton Depression Rating Scale (17 item version) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2008

Arms	Assigned Interventions
Active Comparator: 1 Olanzapine 5 mg / day	Drug: Olanzapine Olanzapine 5 mg / day for 6 months Other Name: EU/1/96/022/002+019
Placebo Comparator: 2 Placebo	Drug: Olanzapine Olanzapine 5 mg / day for 6 months Other Name: EU/1/96/022/002+019

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568672

Locations

Germany
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin
Berlin, Germany, 14050

Sponsors and Collaborators

Charite University, Berlin, Germany

Eli Lilly and Company

Investigators

Principal Investigator:	Ion Anghelescu, MD	Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
Principal Investigator:	Arnim Quante, MD	Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prof. Ion Anghelescu, MD, Charité University Berlin
ClinicalTrials.gov Identifier:	NCT00568672 History of Changes
Other Study ID Numbers:	2007-000512-82, Franziska Jakob, MD, Ion Anghelescu, MD
Study First Received:	December 5, 2007
Last Updated:	April 23, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

Major Depression
Olanzapine
add-on therapy
antidepressant
atypical antipsychotic

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012