Try our beta test site

Natural Supplements for Unipolar Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Cambridge Health Alliance.
Recruitment status was:  Recruiting
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Cambridge Health Alliance Identifier:
First received: September 12, 2005
Last updated: October 19, 2006
Last verified: October 2006
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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: September 2005
Detailed Description:
The study is 6 weeks long, with 9 clinical visits.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00226356

Contact: Vanessa Stan, AB 617-591-6116

United States, Massachusetts
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Vanessa Stan, AB    617-591-6116   
Principal Investigator: Robert T Dunn, MD, PhD         
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 Identifier: NCT00226356     History of Changes
Other Study ID Numbers: CHA-IRB-0048/04/04 
Study First Received: September 12, 2005
Last Updated: October 19, 2006

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 February 24, 2017