search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
S-adenosyl-l-methionine
Escitalopram
Placebo
Sponsored by
Maurizio Fava, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Antidepressive Agents, Complementary Therapies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

S-adenosyl-l-methionine (SAMe)

2. Escitalopram

3. placebo

Arm Description

A natural substance

A selective serotonin reuptake inhibitor (SSRI)

Sugar pill- contains no active ingredients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2005
Last Updated
March 6, 2017
Sponsor
Maurizio Fava, MD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00101452
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maurizio Fava, MD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Antidepressive Agents, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-adenosyl-l-methionine (SAMe)
Arm Type
Experimental
Arm Description
A natural substance
Arm Title
2. Escitalopram
Arm Type
Active Comparator
Arm Description
A selective serotonin reuptake inhibitor (SSRI)
Arm Title
3. placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill- contains no active ingredients
Intervention Type
Drug
Intervention Name(s)
S-adenosyl-l-methionine
Other Intervention Name(s)
SAMe
Intervention Description
1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules look like escitalopram capsules and SAMe capsules
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Fava, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24500245
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.
Results Reference
result
PubMed Identifier
26011569
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.
Results Reference
result
PubMed Identifier
25470103
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.
Results Reference
result
PubMed Identifier
30245644
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.
Results Reference
derived
PubMed Identifier
25055809
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs