Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
NCT ID: NCT00093847
Last Updated: 2014-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2004-05-31
2009-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 Oral SAMe Tosylate
Participants receiving the oral SAMe tosylate
S-adenosyl methione (SAMe)
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
2 Oral Placebo Pill Twice Daily
Participants receiving placebo
Placebo
Placebo to be taken daily for 6 weeks
Interventions
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S-adenosyl methione (SAMe)
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
Placebo
Placebo to be taken daily for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Use of an SSRI for at least 6 weeks prior to study entry with partial or no response
Exclusion Criteria
* Allergy to SAMe
* Alcohol or drug abuse in the past 3 months prior to study entry
18 Years
80 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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George I. Papakostas
Principal Investigator
Principal Investigators
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George I. Papakostas, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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