Prospective, randomised evaluation of efficacy of antidepressant monotherapy and antidepressant combinations in the treatment of patients with resistant depressio

Completed

• Conditions: Resistant depressive disorder; Mental and Behavioural Disorders; Recurrent depressive disorder

• Registration Number: ISRCTN65259480
• Lead Sponsor: Ministry of Health (Czech Republic) - Internal Grant Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0.
2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997
3. The mental ability to understand and sign Informed Consent Form
4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4
5. Outpatients and inpatients
6. Age between 18 and 65 years

Exclusion Criteria

1. Contraindications of used antidepressant treatments according to Summary of product (SPC)
2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode
3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy
4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study
5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified