Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial
Primary Purpose
Therapy-resistant Depression
Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Therapy-resistant Depression focused on measuring Therapy-resistant depression, add-on therapy depression
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: bipolar disorder active alcohol or illicit drug use female with ineffective contraception severe medical conditions, epilepsy psychotic features
Sites / Locations
- Dept. of Psychiatry, University of Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
olanzapine
placebo
Arm Description
10 mg Olanzapine
Placebo
Outcomes
Primary Outcome Measures
Hamilton-Depression-Scale- HAM-D
Secondary Outcome Measures
rate of remission (HAM-D less or equal 7)
differences in HAM-D total scores
differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores
predictive value of HAM-D subscales for treatment response use of comedication
survival in study
differences in rates of adverse events, weight
differences in HAM-D scores and survival in extension phase
Full Information
NCT ID
NCT00273624
First Posted
January 4, 2006
Last Updated
August 8, 2022
Sponsor
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT00273624
Brief Title
Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial
Official Title
Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn before inclusion of first participant for administrative reasons
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study is using a randomized double-blind, parallel-group, placebo-controlled design. 30 patients per treatment group will be included into the study and randomized to the treatment groups using a computer program. Psychotic features of depression will be excluded by a score of 2 or less in the PANSS subscales P1, P3 and P6. Treatment resistance as defined by history of non-response to two antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. If possible, treatment compliance should be confirmed by plasma level examination. After informed consent, visit 1 is performed on day 0 (inclusion criteria, history, demographics, physical examination, vital signs, HAMD, MADRS, CGI, lab). Study medication is started on day 1, the antidepressive therapy is continued at stable dose until the end of the study. Patients will receive a double-blind therapy of either 10 mg/d olanzapine or placebo. Study visits will be performed on days 4, 7, and 14 (visits 2-4: vital signs, HAMD, MADRS, CGI, lab).
After 14 days, the patients will be classified as responders or non-responders. A responder is defined by a reduction of the initial HAM-D score of more than 50%. Study treatment will be stopped in non-responders and continued in a double-blind manner in responders for further 60 days. Thereafter, the the study medication is stopped and the patients are observed for further 14 days. Study visits will be performed every 14 days. This extension phase was added to examine if a prolonged treatment with olanzapine could ensure a sustained treatment effect. It should be excluded that olanzapine has a short-term tranquillizer-like effect or leads to unfavourable medium- to-long-term depressiogenic effects as observed with other neuroleptics used in depression ( e.g. fluspirilene). Moreover, withdrawal effects should be excluded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy-resistant Depression
Keywords
Therapy-resistant depression, add-on therapy depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
olanzapine
Arm Type
Experimental
Arm Description
10 mg Olanzapine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
10 mg Olanzapin concurrent to antidepressive medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Hamilton-Depression-Scale- HAM-D
Time Frame
14 days
Secondary Outcome Measure Information:
Title
rate of remission (HAM-D less or equal 7)
Time Frame
14 days
Title
differences in HAM-D total scores
Time Frame
14 days
Title
differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores
Time Frame
14 days
Title
predictive value of HAM-D subscales for treatment response use of comedication
Time Frame
14 days
Title
survival in study
Time Frame
14 days
Title
differences in rates of adverse events, weight
Time Frame
14 days
Title
differences in HAM-D scores and survival in extension phase
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
bipolar disorder
active alcohol or illicit drug use
female with ineffective contraception
severe medical conditions, epilepsy
psychotic features
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Normann, MD
Organizational Affiliation
Department of Psychiatry, University of Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychiatry, University of Freiburg
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial
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