Natural Supplements for Unipolar Depression

This study has been completed.

Sponsor:

Collaborator:

National Alliance for Research on Schizophrenia and Depression

Information provided by (Responsible Party):

Cambridge Health Alliance

ClinicalTrials.gov Identifier:

NCT00226356

First received: September 12, 2005

Last updated: April 17, 2017

Last verified: April 2017

History of Changes

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 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:

MedlinePlus related topics: B Vitamins Dietary Supplements Folic Acid

Drug Information available for: Folic acid Racemethionine Methionine Betaine Betaine hydrochloride Vitamin B Complex

U.S. FDA Resources

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.

Eligibility


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

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

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 ClinicalTrials.gov identifier: NCT00226356

Locations


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

Investigators


Principal Investigator:	Robert T Dunn, MD, PhD	Cambridge Health Alliance

More Information


Responsible Party:	Cambridge Health Alliance
ClinicalTrials.gov 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:


Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Folic Acid Vitamin B Complex Betaine Hematinics Vitamins	Micronutrients Growth Substances Physiological Effects of Drugs Gastrointestinal Agents Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 26, 2017

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