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OpenTrials
Completed

NCT Number: NCT00226356

Natural Supplements for Unipolar Depression

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

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Key information

Conditions

Unipolar Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplements of L-methionine, betaine and folate

Drug

Primary outcomes

  1. Depressive symptoms

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 27, 2005
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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