Assessment of Augmentation Strategies to Optimize the Therapeutic Response to Mirtazapine in Major Depressio

Completed

• Conditions: Major depression; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN44468346
• Lead Sponsor: Organon International Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients between 18 and 65 years of age
2. Diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) (American Psychiatric Association, 1994) using the Structural Clinical Interview for DSM-IV (SCID) (Spitzer and Williams, 1988)
3. Initial global score 18 on the first 17 items of the 24-item Hamilton Depression Rating Scale
4. Written informed consent signed by the patient

Exclusion Criteria

1. Patients who have not participated in another clinical trial in the past 30 days
2. Evidence of suicidal tendencies
3. Evidence of significant physical illness contraindicating the use of fluoxetine, mirtazapine, venlafaxine or bupropion, found on physical or in the laboratory data obtained during the first week of the study
4. Mental retardation (Intelligence Quotient [IQ] lower than 80) rendering the response to investigators unreliable
5. Pregnancy, or absence of adequate contraceptive method in women with childbearing potential
6. Concurrent use of psychotropic medication such as neuroleptics, mood stabilizers or regular use of high doses of benzodiazepines
7. Lack of response to fluoxetine for the present episode

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy variables are the total Hamilton Depression Rating Scale (HAM-D), total Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI) improvement scale, CGI severity scale, the percentage of responders (i.e. improvement of 50% or more on the total MADRS), and the percentage of remitters (i.e. a score of 8 or less on the HAM-D)

Secondary Outcome Measures

Name	Time	Method
The secondary variable is the depression subscale of the Symptom Checklist-90-R (SCL-90-R)