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

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 III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

S-Adenosylmethionine Methionine Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), 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 as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Depressive scales [ Time Frame: Measured at Week 6 ]

Secondary Outcome Measures:

Self-report depression questionnaires [ Time Frame: Measured at Week 6 ]

Estimated Enrollment:	80
Study Start Date:	May 2004
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental Participants receiving the oral SAMe tosylate	Drug: S-adenosyl methione (SAMe) Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
2: Placebo Comparator Participants receiving placebo	Drug: Placebo Placebo to be taken daily for 6 weeks

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

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

Locations


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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	George I. Papakostas, MD	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:	K23 MH69629, DATR AK-TNET1
First Received:	October 6, 2004
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00093847
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Selective Serotonin Reuptake Inhibitors

S-adenosyl Methionine

SSRI

SAMe

Study placed in the following topic categories:

Depression

Mood Disorders

Depressive Disorder

Serotonin

Additional relevant MeSH terms:

Mental Disorders

Behavioral Symptoms

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00093847