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This study has been withdrawn prior to enrollment.
(Withdrawn because of personal ressources before inclusion of the first patient)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00568672
First received: December 5, 2007
Last updated: April 23, 2008
Last verified: April 2008
  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 3

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:


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
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, see Learn About Clinical Studies.

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:
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 July 26, 2014