Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273624
Status:
WITHDRAWN
Last Update Posted:
2022-08-10
First Post:
2006-01-04
Brief Title:
Olanzapine Augmentation Therapy in Treatment-resistant Depression a Double-blind Placebo-controlled Trial
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Olanzapine Augmentation Therapy in Treatment-resistant Depression a Double-blind Placebo-controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn before inclusion of first participant for administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 symptomsthe 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 mgd 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 eg fluspirilene Moreover withdrawal effects should be excluded
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 eg fluspirilene Moreover withdrawal effects should be excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None