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

Primary Purpose

Relapse Rate of a Major Depressive Episode, Safety of Olanzapine in Subjects With Major Depression

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse Rate of a Major Depressive Episode focused on measuring Major Depression, Olanzapine, add-on therapy, antidepressant, atypical antipsychotic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Olanzapine 5 mg / day

Placebo

Outcomes

Primary Outcome Measures

Relapse Rate, Hamilton Depression Rating Scale (17 item version)

Secondary Outcome Measures

Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory

Full Information

First Posted
December 5, 2007
Last Updated
February 7, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00568672
Brief Title
Optimal Duration of Olanzapine Add-on Therapy in Major Depression
Acronym
OLA-D
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn because of personal ressources before inclusion of the first patient
Study Start Date
October 2007 (Anticipated)
Primary Completion Date
January 2008 (Anticipated)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse Rate of a Major Depressive Episode, Safety of Olanzapine in Subjects With Major Depression
Keywords
Major Depression, Olanzapine, add-on therapy, antidepressant, atypical antipsychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Olanzapine 5 mg / day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
EU/1/96/022/002+019
Intervention Description
Olanzapine 5 mg / day for 6 months
Primary Outcome Measure Information:
Title
Relapse Rate, Hamilton Depression Rating Scale (17 item version)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ion Anghelescu, MD
Organizational Affiliation
Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnim Quante, MD
Organizational Affiliation
Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
14050
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://psychiatrie.charite.de/
Description
Related Info

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Optimal Duration of Olanzapine Add-on Therapy in Major Depression

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