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Natural Supplements for Unipolar Depression

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. Identifier: NCT00226356
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 18, 2017
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Cambridge Health Alliance

Brief Summary:
This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : December 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : September 17, 2008

Arm Intervention/treatment
Experimental: Supplements of L-methionine, betaine and folate Drug: Supplements of L-methionine, betaine and folate

Primary Outcome Measures :
  1. Depressive symptoms

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.

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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

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 identifier (NCT number): NCT00226356

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

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Responsible Party: Cambridge Health Alliance Identifier: NCT00226356    
Other Study ID Numbers: CHA-IRB-0048/04/04
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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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