Trial record 2 of 4 for: SAMS NIMH

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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

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 3

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) Augmenation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin Methionine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Depressive scales [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-report depression questionnaires [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
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 Participants receiving the oral SAMe tosylate	Drug: S-adenosyl methione (SAMe) Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
Placebo Comparator: 2 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
Boston, Massachusetts, United States, 02114

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mischoulon D, Alpert JE, Arning E, Bottiglieri T, Fava M, Papakostas GI. Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder. J Clin Psychiatry. 2012 Jun;73(6):843-8. Epub 2012 May 15.

Dording CM, Mischoulon D, Shyu I, Alpert JE, Papakostas GI. SAMe and sexual functioning. Eur Psychiatry. 2012 Aug;27(6):451-4. Epub 2011 Mar 12.

Papakostas GI, Mischoulon D, Shyu I, Alpert JE, Fava M. S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial. Am J Psychiatry. 2010 Aug;167(8):942-8. Epub 2010 Jul 1.

Responsible Party:	George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00093847 History of Changes
Other Study ID Numbers:	K23 MH069629, DATR AK-TNET1
Study First Received:	October 6, 2004
Last Updated:	March 10, 2009
Health Authority:	United States: Federal Government

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

Selective Serotonin Reuptake Inhibitors
S-adenosyl Methionine
SSRI
SAMe

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
Serotonin Uptake Inhibitors

Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

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