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

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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Depressive scales [ Time Frame: Measured at Week 6 ]

Secondary Outcome Measure ^†

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

Condition ^†

Depression

Intervention ^†

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

MEDLINE PMIDs

14609501

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

May 2004

Completion Date

November 2008

Eligibility 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00093847

Organization ID

K23 MH69629

Secondary IDs ^††

DATR AK-TNET1

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

George I. Papakostas, MD

Massachusetts General Hospital

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

November 2007

First Received Date ^†

October 6, 2004

Last Updated Date

November 27, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.