NCT00093847

Brief Summary

This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started May 2004

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

4.8 years

First QC Date

October 6, 2004

Results QC Date

April 25, 2012

Last Update Submit

October 10, 2014

Conditions

Depression

Keywords

Selective Serotonin Reuptake InhibitorsS-adenosyl MethionineSSRISAMe

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale Remission Rates

    The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .

    Measured at Week 6

Secondary Outcomes (1)

  • HDRS17 Responders

    Measured at Week 6

Study Arms (2)

1 Oral SAMe Tosylate

EXPERIMENTAL

Participants receiving the oral SAMe tosylate

Drug: S-adenosyl methione (SAMe)

2 Oral Placebo Pill Twice Daily

PLACEBO COMPARATOR

Participants receiving placebo

Drug: Placebo

Interventions

S-adenosyl methione (SAMe)DRUG

Oral SAMe tosylate, up to 1600 mg per day for 6 weeks

Also known as: Oral SAMe tosylate
1 Oral SAMe Tosylate
PlaceboDRUG

Placebo to be taken daily for 6 weeks

Also known as: Pill identical in appearance to drug but placebo
2 Oral Placebo Pill Twice Daily

Eligibility Criteria

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

You may qualify if:

  • Major depressive disorder
  • Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

You may not qualify if:

  • History of psychosis
  • Allergy to SAMe
  • Alcohol or drug abuse in the past 3 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Papakostas GI, Alpert JE, Fava M. S-adenosyl-methionine in depression: a comprehensive review of the literature. Curr Psychiatry Rep. 2003 Dec;5(6):460-6. doi: 10.1007/s11920-003-0085-2.

    PMID: 14609501BACKGROUND

  • Papakostas GI, Mischoulon D, Shyu I, Alpert JE, Fava M. S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial. Am J Psychiatry. 2010 Aug;167(8):942-8. doi: 10.1176/appi.ajp.2009.09081198. Epub 2010 Jul 1.

    PMID: 20595412RESULT

  • Mischoulon D, Alpert JE, Arning E, Bottiglieri T, Fava M, Papakostas GI. Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder. J Clin Psychiatry. 2012 Jun;73(6):843-8. doi: 10.4088/JCP.11m07139. Epub 2012 May 15.

    PMID: 22687580DERIVED

  • Dording CM, Mischoulon D, Shyu I, Alpert JE, Papakostas GI. SAMe and sexual functioning. Eur Psychiatry. 2012 Aug;27(6):451-4. doi: 10.1016/j.eurpsy.2011.01.003. Epub 2011 Mar 12.

    PMID: 21398094DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr George Papakostas, M.D.
Organization
Massachusetts General Hospital
gpapakstas@partners.org
6177266697

Study Officials

  • George I. Papakostas, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

May 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 13, 2014

Results First Posted

October 13, 2014

Record last verified: 2014-10

Locations

US(1)