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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 19, 2006

Start Date ^ICMJE

December 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Depressive symptoms

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00226356 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Natural Supplements for Unipolar Depression

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Unipolar Depression

Intervention ^ICMJE

Drug: Supplements of L-methionine, betaine and folate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Vanessa Stan, AB

617-591-6116

vstan@challiance.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00226356

Other Study ID Numbers ^ICMJE

CHA-IRB-0048/04/04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cambridge Health Alliance

Collaborators ^ICMJE

National Alliance for Research on Schizophrenia and Depression

Investigators ^ICMJE

Principal Investigator:

Robert T Dunn, MD, PhD

Cambridge Health Alliance

Information Provided By

Cambridge Health Alliance

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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