NCT00273624

Brief Summary

60 patients with major depression will be treated with 10 mg Olanzapine or Placebo for 2 weeks. In case of response (reduction of depressive symptoms)the study will be continued for further 60 days.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

4.5 years

First QC Date

January 4, 2006

Last Update Submit

August 8, 2022

Conditions

Therapy-resistant Depression

Keywords

Therapy-resistant depressionadd-on therapy depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton-Depression-Scale- HAM-D

    14 days

Secondary Outcomes (7)

  • rate of remission (HAM-D less or equal 7)

    14 days

  • differences in HAM-D total scores

    14 days

  • differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores

    14 days

  • predictive value of HAM-D subscales for treatment response use of comedication

    14 days

  • survival in study

    14 days

  • +2 more secondary outcomes

Study Arms (2)

olanzapine

EXPERIMENTAL

10 mg Olanzapine

Drug: Olanzapine

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

OlanzapineDRUG

10 mg Olanzapin concurrent to antidepressive medication

Also known as: Zyprexa
olanzapine
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major depression without psychotic features
  • therapy resistance (2 courses of antidepressants from different classes for more than 3 weeks in adequate dose
  • HAM-D score greater/equal than 17
  • age 18-65

You may not qualify if:

  • bipolar disorder
  • active alcohol or illicit drug use
  • female with ineffective contraception
  • severe medical conditions, epilepsy
  • psychotic features

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry, University of Freiburg

Freiburg im Breisgau, 79104, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Claus Normann, MD

    Department of Psychiatry, University of Freiburg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

DE(1)