Natural Supplements for Unipolar Depression
Sponsor
Cambridge Health Alliance (Other)
Overall Status
Completed
CT.gov ID
NCT00226356
Collaborator
National Alliance for Research on Schizophrenia and Depression (Other)
20
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45.5
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Jun 1, 2007
Actual Study Completion Date
:
Sep 17, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supplements of L-methionine, betaine and folate
|
Drug: Supplements of L-methionine, betaine and folate
|
Outcome Measures
Primary Outcome Measures
- Depressive symptoms []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00226356
Other Study ID Numbers:
- CHA-IRB-0048/04/04
First Posted:
Sep 27, 2005
Last Update Posted:
Apr 18, 2017
Last Verified:
Apr 1, 2017