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Awarded Trial: 97-RC-299-1
Grant ID
97-RC-299-1
Illness
Bipolar Disorder
Primary Drug/Intervention
S-adenosyl-methionine (SAMe)
Primary Dosage
1600 mg/day
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Cohen
Sample Size
15
Duration of Study Period for Each Subject
4 weeks
Outcome Measurements
Pharmacokinetic parameters
Results
Sixteen normal control subjects received s-adenosyl methionine (up to 1600 mg per day) for four weeks. Treatment was not associated with increased serum levels of toxic methylated compounds such as methanol, formic acid, or formaldehyde. Homocysteine levels were also measured and did not increase with treatment. Treatment was generally well-tolerated, although one patient experienced a mixed manic mood episode.
Publication
Gören JL, Stoll AL, Damico KE, Sarmiento IA, Cohen BM. Bioavailability and lack of toxicity of S-Adenosyl-L-methioine (SAMe) in humans. Pharmacotherapy. 24 (1): 1501-1507, 2004.
Link
http://www.ncbi.nlm.nih.gov/pubmed/15537554
PI Name
Bruce Cohen
Degree
MD
Center
N/A
Institution
N/A
Address
N/ACity or Town
Bemont
State or Province
MA
Zip or Postal Code
N/A
Country
USA
Email Address
cohenb@mclean.harvard.edu