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

February 7, 2023 updated by: Arnim Quante, Charite University, Berlin, Germany

Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: Olanzapine
Olanzapine 5 mg / day for 6 months
Other Names:
  • EU/1/96/022/002+019
ACTIVE_COMPARATOR: 1
Olanzapine 5 mg / day
Drug: Olanzapine
Olanzapine 5 mg / day for 6 months
Other Names:
  • EU/1/96/022/002+019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse Rate, Hamilton Depression Rating Scale (17 item version)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2007

Primary Completion (ANTICIPATED)

January 1, 2008

Study Completion (ANTICIPATED)

April 1, 2008

Study Registration Dates

First Submitted

December 5, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (ESTIMATE)

December 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-000512-82

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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