Natural Supplements for Unipolar Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Cambridge Health Alliance.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Cambridge Health Alliance
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00226356
First received: September 12, 2005
Last updated: October 19, 2006
Last verified: October 2006
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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
Drug Information available for:
Folic acid
Methionine
Betaine
Betaine hydrochloride
Vitamin B Complex
U.S. FDA Resources
Further study details as provided by Cambridge Health Alliance:
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226356
Contacts
| Contact: Vanessa Stan, AB | 617-591-6116 | vstan@challiance.org |
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
| ClinicalTrials.gov Identifier: | NCT00226356 History of Changes |
| Other Study ID Numbers: | CHA-IRB-0048/04/04 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 19, 2006 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Betaine Folic Acid Vitamin B Complex Gastrointestinal Agents Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hematinics Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016