Natural Supplements for Unipolar Depression

This study is currently recruiting participants.

Verified by Cambridge Health Alliance, October 2006

Sponsors and Collaborators:	Cambridge Health Alliance National Alliance for Research on Schizophrenia and Depression
Information provided by:	Cambridge Health Alliance
ClinicalTrials.gov Identifier:	NCT00226356

Purpose

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 IV

MedlinePlus related topics: Depression Dietary Supplements

Drug Information available for: Folic acid Methionine Betaine Betaine hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:

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.

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226356

Contacts

Contact: Vanessa Stan, AB

617-591-6116

Locations

United States, Massachusetts
Cambridge Health Alliance	Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Vanessa Stan, AB 617-591-6116 vstan@challiance.org
Principal Investigator: Robert T Dunn, MD, PhD

Sponsors and Collaborators

Cambridge Health Alliance

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Robert T Dunn, MD, PhD

Cambridge Health Alliance

More Information

Study ID Numbers:	CHA-IRB-0048/04/04
Study First Received:	September 12, 2005
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00226356
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Folic Acid
Depression
Mental Disorders
Mood Disorders

Depressive Disorder
Betaine
Behavioral Symptoms

Additional relevant MeSH terms:

Antimetabolites
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009