NCT00101452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 31, 2012

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

5.2 years

First QC Date

January 10, 2005

Results QC Date

June 13, 2012

Last Update Submit

March 6, 2017

Conditions

Depression

Keywords

DepressionAntidepressive AgentsComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

S-adenosyl-l-methionine (SAMe)

EXPERIMENTAL

A natural substance

Drug: S-adenosyl-l-methionine

2. Escitalopram

ACTIVE COMPARATOR

A selective serotonin reuptake inhibitor (SSRI)

Drug: Escitalopram

3. placebo

PLACEBO COMPARATOR

Sugar pill- contains no active ingredients

Drug: Placebo

Interventions

S-adenosyl-l-methionineDRUG

1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks

Also known as: SAMe
S-adenosyl-l-methionine (SAMe)
EscitalopramDRUG

10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks

Also known as: Lexapro
2. Escitalopram
PlaceboDRUG

placebo capsules look like escitalopram capsules and SAMe capsules

3. placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (5)

  • 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.

    PMID: 24500245RESULT

  • 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.

    PMID: 26011569RESULT

  • 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.

    PMID: 25470103RESULT

  • 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.

    PMID: 30245644DERIVED

  • 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.

    PMID: 25055809DERIVED

MeSH Terms

Conditions

Depression

Interventions

S-AdenosylmethionineEscitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesPropylaminesAminesNitrilesBenzofurans

Results Point of Contact

Title
Maurizio Fava
Organization
Massachusetts General Hospital
mfava@partners.org
617-724-2513

Study Officials

  • Maurizio Fava, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director- Depression Clinical and Research Program

Study Record Dates

First Submitted

January 10, 2005

First Posted

January 11, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 4, 2017

Results First Posted

December 31, 2012

Record last verified: 2017-03

Locations

US(2)