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

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

Some people with depression do not respond well to antidepressant treatment. The purpose of this study is to determine whether adding another substance to an antidepressant drug treatment regimen can reduce depressive symptoms in patients currently taking antidepressant drugs but are not responsive to them.

Condition Treatment or Intervention Phase
Depression
 Drug: S-adenosyl methione (SAMe)
Phase III

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: S-adenosyl Methionine (SAMe) Augmenation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

Further Study Details: 

Expected Total Enrollment:  80

Study start: May 2004

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.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
George I. Papakostas, MD  617-726-6697    gpapakostas@partners.org 
George I. Papakostas, MD,  Principal Investigator

Study chairs or principal investigators

George I. Papakostas, MD,  Principal Investigator,  Massachusetts General Hospital   

More Information

Publications

Papakostas GI, Alpert JE, Fava M. S-adenosyl-methionine in depression: a comprehensive review of the literature. Curr Psychiatry Rep. 2003 Dec;5(6):460-6. Review.

Study ID Numbers:  5K23 MH069629-01/2
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093847
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005