Back to resultsNatural Supplements for Unipolar Depression
Primary Purpose
Unipolar Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Supplements of L-methionine, betaine and folate
Sponsored by
About this trial
This is an interventional treatment trial for Unipolar Depression
Eligibility 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
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supplements of L-methionine, betaine and folate
Arm Description
Outcomes
Primary Outcome Measures
Depressive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00226356
First Posted
September 12, 2005
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00226356
Brief Title
Natural Supplements for Unipolar Depression
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
September 17, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
5. Study Description
Brief Summary
This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.
Detailed Description
The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplements of L-methionine, betaine and folate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Supplements of L-methionine, betaine and folate
Primary Outcome Measure Information:
Title
Depressive symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Dunn, MD, PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Natural Supplements for Unipolar Depression
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