Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: Placebo; Drug: S-adenosyl methione (SAMe)

• Registration Number: NCT00093847
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

Detailed Description

Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.

This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-10-06
• Study First Submitted QC: 2004-10-07
• Study First Posted: 2004-10-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-04-25
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-10
• Last Update Submitted: 2014-10-10
• Results First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Major depressive disorder
• Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

Exclusion Criteria

• History of psychosis
• Allergy to SAMe
• Alcohol or drug abuse in the past 3 months prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 Oral Placebo Pill Twice Daily	Placebo	Participants receiving placebo
1 Oral SAMe Tosylate	S-adenosyl methione (SAMe)	Participants receiving the oral SAMe tosylate

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale Remission Rates	Measured at Week 6	The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .

Secondary Outcome Measures

Name	Time	Method
HDRS17 Responders	Measured at Week 6	35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States