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Natural Supplements for Unipolar Depression

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00226356

First Posted: September 27, 2005

Last Update Posted: April 18, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Alliance for Research on Schizophrenia and Depression

Information provided by (Responsible Party):

Cambridge Health Alliance

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: None (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:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	September 12, 2005
First Posted:	September 27, 2005
Last Update Posted:	April 18, 2017
Last Verified:	April 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

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