Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression

Depression Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101452
• Other study ID #: R01AT001638-01A1
• Secondary ID: R01AT001638-01A1
• Status: Completed
• Phase: N/A
• First received: January 10, 2005
• Last updated: April 7, 2015
• Start date: April 2005
• Est. completion date: June 2010

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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 be switched to treatment with both 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• S-adenosyl-l-methionine
1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
• Escitalopram
10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
• Placebo
placebo capsules look like escitalopram capsules and SAMe capsules

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Maurizio Fava, MD	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAM-D)	The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.	baseline and 24 weeks	Yes