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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00093847
First received: October 6, 2004
Last updated: March 10, 2009
Last verified: March 2009
History of Changes

October 6, 2004
March 10, 2009
May 2004
February 2009   (final data collection date for primary outcome measure)
Depressive scales [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00093847 on ClinicalTrials.gov Archive Site
Self-report depression questionnaires [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
S-Adenosyl Methionine (SAMe) Augmenation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: S-adenosyl methione (SAMe)
    Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
  • Drug: Placebo
    Placebo to be taken daily for 6 weeks
  • Experimental: 1
    Participants receiving the oral SAMe tosylate
    Intervention: Drug: S-adenosyl methione (SAMe)
  • Placebo Comparator: 2
    Participants receiving placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00093847
K23 MH069629, DATR AK-TNET1
Not Provided
George I. Papakostas, Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: George I. Papakostas, MD Massachusetts General Hospital
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP