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Natural Supplements for Unipolar Depression

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ClinicalTrials.gov Identifier: NCT00226356
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Cambridge Health Alliance

Study Description
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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
Unipolar Depression Drug: Supplements of L-methionine, betaine and folate 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : September 17, 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Supplements of L-methionine, betaine and folate Drug: Supplements of L-methionine, betaine and folate


Outcome Measures
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Primary Outcome Measures :
  1. Depressive symptoms

Eligibility Criteria
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226356


Locations
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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
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Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance
More Information
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Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00226356    
Other Study ID Numbers: CHA-IRB-0048/04/04
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Betaine
 Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents