We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00568672
Recruitment Status : Withdrawn (Withdrawn because of personal ressources before inclusion of the first patient)
First Posted : December 6, 2007
Last Update Posted : April 25, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Relapse Rate of a Major Depressive Episode Safety of Olanzapine in Subjects With Major Depression Drug: Olanzapine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2007
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Drug: Olanzapine
Olanzapine 5 mg / day for 6 months
Other Name: EU/1/96/022/002+019

Outcome Measures

Primary Outcome Measures :
  1. Relapse Rate, Hamilton Depression Rating Scale (17 item version) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568672

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
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

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
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by Charite University, Berlin, Germany:
Major Depression
add-on therapy
atypical antipsychotic

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents