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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00093847
First received: October 6, 2004
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Depression
Drug: S-adenosyl methione (SAMe)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale Remission Rates [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
    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:
  • HDRS17 Responders [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
    35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .


Enrollment: 73
Study Start Date: May 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Oral SAMe Tosylate
Participants receiving the oral SAMe tosylate
Drug: S-adenosyl methione (SAMe)
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
Other Name: Oral SAMe tosylate
Placebo Comparator: 2 Oral Placebo Pill Twice Daily
Participants receiving placebo
Drug: Placebo
Placebo to be taken daily for 6 weeks
Other Name: Pill identical in appearance to drug but placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093847

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: George I. Papakostas, MD Massachusetts General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George I. Papakostas, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00093847     History of Changes
Other Study ID Numbers: K23 MH069629, K23MH069629
Study First Received: October 6, 2004
Results First Received: April 25, 2012
Last Updated: October 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Selective Serotonin Reuptake Inhibitors
S-adenosyl Methionine
SSRI
SAMe

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders
Serotonin
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on October 23, 2014