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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
Sponsor:
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
  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:


Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Depressive symptoms

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: September 2005
Detailed Description:

The study is 6 weeks long, with 9 clinical visits.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
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

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

No publications provided

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
Mental Disorders
Mood Disorders
Betaine
Antimetabolites
Gastrointestinal Agents
Hypolipidemic Agents
Lipid Regulating Agents
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014