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

Tracking Information

First Received Date ^ICMJE

October 6, 2004

Last Updated Date

March 10, 2009

Start Date ^ICMJE

May 2004

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Depressive scales [ Time Frame: Measured at Week 6 ]

Change History

Complete list of historical versions of study NCT00093847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

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) Augmenation 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: S-adenosyl methione (SAMe)
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Participants receiving the oral SAMe tosylate
Placebo Comparator: Participants receiving placebo

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2009

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00093847

Responsible Party

George I. Papakostas, Massachusetts General Hospital

Study ID Numbers ^ICMJE

K23 MH069629, DATR AK-TNET1

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

George I. Papakostas, MD

Massachusetts General Hospital

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2009

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