Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial

Therapy-resistant Depression Clinical Trial

Official title:

Olanzapine Augmentation Therapy in Treatment-resistant Depression: a Double-blind Placebo-controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00273624
• Other study ID #: Olanzapine Augmentation
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: August 2022
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Therapy-resistant Depression

Intervention

Drug:
• Olanzapine
10 mg Olanzapin concurrent to antidepressive medication
• Placebo
placebo

Locations

Country	Name	City	State
Germany	Dept. of Psychiatry, University of Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton-Depression-Scale- HAM-D		14 days
Secondary	rate of remission (HAM-D less or equal 7)		14 days
Secondary	differences in HAM-D total scores		14 days
Secondary	differences in MADRS (Montgomery Asberg Depression Rating Scale)and CGI (Clinical Global Impression)scores		14 days
Secondary	predictive value of HAM-D subscales for treatment response use of comedication		14 days
Secondary	survival in study		14 days
Secondary	differences in rates of adverse events, weight		14 days
Secondary	differences in HAM-D scores and survival in extension phase		2 months