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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Depression

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00093847

K23MH069629 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

1 Oral SAMe Tosylate

Experimental group

Description:

Participants receiving the oral SAMe tosylate

Treatment:

Drug: S-adenosyl methione (SAMe)

2 Oral Placebo Pill Twice Daily

Placebo Comparator group

Description:

Participants receiving placebo

Treatment:

Drug: Placebo