Clinical trial NCT00101452: Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
Official title: A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Antidepressive Agents
Complementary Therapies
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-01-11
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.

Detailed description: SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug. Although SAMe has not yet been approved for treating depression, evidence suggests that it has antidepressant properties. This study will determine whether SAMe is safe and effective in treating major depression.

This study will last 24 weeks. Participants will be randomly assigned to receive either the antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks. Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report questionnaires will be used to assess participants. All participants will receive 3 months of follow-up care, including free medication and clinic visits as necessary.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depression
* Score of 25 or higher on the Inventory of Depressive Symptomatology (IDS-C) scale
* Score of higher than 2 on the Clinical Global Impression Improvement (CGI) scale
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Suicidal or homicidal
* Unstable illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* Any of the following mental conditions: organic mental disorders; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; recent bereavement; severe borderline or antisocial personality disorder; panic disorder; or obsessive compulsive disorder
* Substance abuse, including alcohol abuse, within 6 months prior to study entry
* Uncontrolled seizure disorder, or a seizure disorder controlled with psychotropic anticonvulsants
* Psychotic features
* Current use of other psychotropic drugs
* Hypothyroidism
* Have taken 6 weeks or more of either escitalopram or SAMe during the current depressive episode
* Previous intolerance of SAMe or escitalopram
* Investigational psychotropic drugs within 1 year prior to study entry
* Have received two or more antidepressant therapies of adequate doses and duration and failed to respond
* Have received depression-focused psychotherapy
* Bleeding tissue disorder, low platelet counts, a history of GI bleeding, or use of medications that alter bleeding risk
* Long-term aspirin use
* Pregnancy

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: baseline and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Massachusetts General Hospital
name: Maurizio Fava, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mischoulon D, Price LH, Carpenter LL, Tyrka AR, Papakostas GI, Baer L, Dording CM, Clain AJ, Durham K, Walker R, Ludington E, Fava M. A double-blind, randomized, placebo-controlled clinical trial of S-adenosyl-L-methionine (SAMe) versus escitalopram in major depressive disorder. J Clin Psychiatry. 2014 Apr;75(4):370-6. doi: 10.4088/JCP.13m08591.
citation: Sarris J, Price LH, Carpenter LL, Tyrka AR, Ng CH, Papakostas GI, Jaeger A, Fava M, Mischoulon D. Is S-Adenosyl Methionine (SAMe) for Depression Only Effective in Males? A Re-Analysis of Data from a Randomized Clinical Trial. Pharmacopsychiatry. 2015 Jul;48(4-5):141-4. doi: 10.1055/s-0035-1549928. Epub 2015 May 26.
citation: Mischoulon D, Price LH, Carpenter LL, Tyrka AR, Papakostas GI, Fava M. Dr. Mischoulon and colleagues reply. J Clin Psychiatry. 2014 Nov;75(11):e1328-9. doi: 10.4088/JCP.14lr09266a. No abstract available.
citation: Laferton JAC, Vijapura S, Baer L, Clain AJ, Cooper A, Papakostas G, Price LH, Carpenter LL, Tyrka AR, Fava M, Mischoulon D. Mechanisms of Perceived Treatment Assignment and Subsequent Expectancy Effects in a Double Blind Placebo Controlled RCT of Major Depression. Front Psychiatry. 2018 Sep 7;9:424. doi: 10.3389/fpsyt.2018.00424. eCollection 2018.
citation: Admon R, Nickerson LD, Dillon DG, Holmes AJ, Bogdan R, Kumar P, Dougherty DD, Iosifescu DV, Mischoulon D, Fava M, Pizzagalli DA. Dissociable cortico-striatal connectivity abnormalities in major depression in response to monetary gains and penalties. Psychol Med. 2015 Jan;45(1):121-31. doi: 10.1017/S0033291714001123. Epub 2014 May 15.