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Natural Supplements for Unipolar Depression

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Cambridge Health Alliance Identifier:
First received: September 12, 2005
Last updated: April 17, 2017
Last verified: April 2017
This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.

Condition Intervention Phase
Unipolar Depression
Drug: Supplements of L-methionine, betaine and folate
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-carbon Cycle With L-methionine, Betaine and Folate

Resource links provided by NLM:

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Depressive symptoms

Enrollment: 20
Study Start Date: December 2004
Study Completion Date: September 17, 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplements of L-methionine, betaine and folate Drug: Supplements of L-methionine, betaine and folate

Detailed Description:
The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS > 18; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria:

  • Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00226356

United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance
  More Information

Responsible Party: Cambridge Health Alliance Identifier: NCT00226356     History of Changes
Other Study ID Numbers: CHA-IRB-0048/04/04
Study First Received: September 12, 2005
Last Updated: April 17, 2017

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on May 25, 2017