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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH069629 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Oral SAMe Tosylate | Experimental | Participants receiving the oral SAMe tosylate |
|
| 2 Oral Placebo Pill Twice Daily | Placebo Comparator | Participants receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-adenosyl methione (SAMe) | Drug | Oral SAMe tosylate, up to 1600 mg per day for 6 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George I. Papakostas, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14609501 | Background | 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. doi: 10.1007/s11920-003-0085-2. | |
| 20595412 | Result | 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. doi: 10.1176/appi.ajp.2009.09081198. Epub 2010 Jul 1. |
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This was a randomzized (1:1) double-blind, placebo-controlled adjunct study of oral SAMe tosylate (target doses of 800mg PO BiD) to standard SSRI and SNRI antidepressants for patients with MDD.
73 outpatients with major depressive disorder who were partial- or non-responders to SSRI/SNRI therapy were enrolled in this trial conducted at Massachusetts General Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adjunct Oral SAMe Tosylate 800mg PO BiD | Participants receiving the oral SAMe tosylate |
| FG001 | Oral Adjunct Placebo | Participants receiving placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adjunct Oral SAMe Tosylate 800mg PO BiD | Participants receiving the oral SAMe tosylate |
| BG001 | Oral Adjunct Placebo | Participants receiving placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 . | ITT LOCF | Posted | Number | Percentage of Remitters HDRS17 | Measured at Week 6 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adjunct Oral SAMe Tosylate 800mg PO BiD | Participants receiving the oral SAMe tosylate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr George Papakostas, M.D. | Massachusetts General Hospital | 6177266697 | gpapakstas@partners.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo | Drug | Placebo to be taken daily for 6 weeks |
|
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| 22687580 | Derived | 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. doi: 10.4088/JCP.11m07139. Epub 2012 May 15. |
| 21398094 | Derived | Dording CM, Mischoulon D, Shyu I, Alpert JE, Papakostas GI. SAMe and sexual functioning. Eur Psychiatry. 2012 Aug;27(6):451-4. doi: 10.1016/j.eurpsy.2011.01.003. Epub 2011 Mar 12. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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 . | ITT LOCF | Posted | Number | Percentage of Responders HDRS17 | Measured at Week 6 |
|
|
|
| 0 |
| 39 |
| 20 |
| 39 |
| EG001 | Oral Adjunct Placebo | Participants receiving placebo | 0 | 34 | 19 | 34 |
| Upper gastrointestinal upset | Gastrointestinal disorders | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Somnolence and fatigue | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Activation | Nervous system disorders | Non-systematic Assessment |
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| Vivid dreams | Nervous system disorders | Non-systematic Assessment |
|
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