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Trial record 2 of 7 for:    SAMS NIMH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00093847
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 6, 2004
First Posted Date  ICMJE October 8, 2004
Results First Submitted Date  ICMJE April 25, 2012
Results First Posted Date  ICMJE October 13, 2014
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE May 2004
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Hamilton Depression Rating Scale Remission Rates [ Time Frame: 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 .
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
HDRS17 Responders [ Time Frame: 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 .
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
Official Title  ICMJE S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: S-adenosyl methione (SAMe)
    Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
    Other Name: Oral SAMe tosylate
  • Drug: Placebo
    Placebo to be taken daily for 6 weeks
    Other Name: Pill identical in appearance to drug but placebo
Study Arms  ICMJE
  • Experimental: 1 Oral SAMe Tosylate
    Participants receiving the oral SAMe tosylate
    Intervention: Drug: S-adenosyl methione (SAMe)
  • Placebo Comparator: 2 Oral Placebo Pill Twice Daily
    Participants receiving placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
73
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
80
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00093847
Other Study ID Numbers  ICMJE K23MH069629( U.S. NIH Grant/Contract )
K23MH069629 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party George I. Papakostas, Massachusetts General Hospital
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: George I. Papakostas, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date October 2014

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