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

NCT ID: NCT00273624

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Therapy-resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

olanzapine

10 mg Olanzapine

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

10 mg Olanzapin concurrent to antidepressive medication

placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

Olanzapine

10 mg Olanzapin concurrent to antidepressive medication

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Zyprexa

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Claus Normann

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claus Normann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, University of Freiburg

Locations

Dept. of Psychiatry, University of Freiburg

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

Olanzapine Augmentation

Identifier Type: -

Identifier Source: org_study_id