Benefits of Switching Antidepressants Following Early Nonresponse

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Introduction and Purpose:

Most of the guidelines for the treatment of major depression recommend the use of antidepressants for 4 to 8 weeks. On the other hand, it has been recently reported that they start to show their antidepressant efficacy within a couple of weeks (1,2), contrary to the conventional theory. In addition, a good response (i.e. a 20% reduction in the Montgomery-Åsberg Depression Rating Scale [MADRS]) at week 2 is proposed to be a predictor of subsequent remission at week 6 (3,4), while nonresponse at week 2 could predict unfavourable outcome at week 8 (5). Furthermore, early worsening is suggested to be related to a low rate of remission at weeks 8 and 12(6).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oizumi Hospital
• Treatments: Antidepressive Agents; Paroxetine; Sertraline

Criteria

Inclusion Criteria:

1. Inpatients and outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of major depression disorder (MDD)

2. Have not taken antidepressants for the previous one month

3. Do not have emergent suicidal ideation defined as a score of 4 or less on suicidal thoughts item in the MADRS.

Exclusion Criteria

1. Unstable physical illness or clinically significant neurological disorder

2. Having emergent suicidal idea defined as a score of 5 or more on the suicidal thoughts item in the MADRS.

3. Having history of non-response or intolerance to paroxetine or sertraline.

This study will be conducted with the approval of the Institutional Review Board of each participating hospital, and written informed consent will be obtained from all of the participants after providing a full explanation of the study.