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Natural Supplements for Unipolar Depression

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00226356
First received: September 12, 2005
Last updated: April 17, 2017
Last verified: April 2017
  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: No masking
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

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

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
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

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
Study First Received: September 12, 2005
Last Updated: April 17, 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

ClinicalTrials.gov processed this record on May 25, 2017