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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This study has been withdrawn prior to enrollment.
(Withdrawn because of personal ressources before inclusion of the first patient)
Eli Lilly and Company
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: December 5, 2007
Last updated: April 23, 2008
Last verified: April 2008
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

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

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


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
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Please refer to this study by its identifier: 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 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

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 processed this record on May 25, 2017