Natural Supplements for Unipolar Depression

Unipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226356
• Other study ID #: CHA-IRB-0048/04/04
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 17, 2017
• Start date: December 2004
• Est. completion date: September 17, 2008

Study information

• Verified date: April 2017
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 17, 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Drug:
• Supplements of L-methionine, betaine and folate

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge Health Alliance	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms