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

Study Overview
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Brief Summary
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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
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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.

Official Title
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S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

Conditions
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Depression

Intervention / Treatment
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* Drug: S-adenosyl methione (SAMe)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Oral SAMe Tosylate<br>Participants receiving the oral SAMe tosylate | Drug: S-adenosyl methione (SAMe)<br>* Oral SAMe tosylate, up to 1600 mg per day for 6 weeks<br>* Other names: Oral SAMe tosylate;|
| Placebo Comparator: 2 Oral Placebo Pill Twice Daily<br>Participants receiving placebo | Drug: Placebo<br>* Placebo to be taken daily for 6 weeks<br>* Other names: Pill identical in appearance to drug but placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale Remission Rates | The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item . | Measured at Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS17 Responders | 35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item . | Measured at Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selective Serotonin Reuptake Inhibitors, S-adenosyl Methionine, SSRI, SAMe