Natural Supplements for Unipolar Depression
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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. |
ClinicalTrials.gov Identifier: NCT00226356 |
Recruitment Status :
Completed
First Posted : September 27, 2005
Last Update Posted : April 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unipolar Depression | Drug: Supplements of L-methionine, betaine and folate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
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 |
- Depressive symptoms

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 |
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

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
United States, Massachusetts | |
Cambridge Health Alliance | |
Cambridge, Massachusetts, United States, 02139 |
Principal Investigator: | Robert T Dunn, MD, PhD | Cambridge Health Alliance |
Responsible Party: | Cambridge Health Alliance |
ClinicalTrials.gov 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 |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Betaine |
Gastrointestinal Agents Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |