Natural Supplements for Unipolar Depression

NCT ID: NCT00226356

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-09-17

Brief Summary

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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

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

Conditions

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Unipolar Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplements of L-methionine, betaine and folate

Group Type EXPERIMENTAL

Supplements of L-methionine, betaine and folate

Intervention Type DRUG

Interventions

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Supplements of L-methionine, betaine and folate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert T Dunn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge Health Alliance

Locations

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Cambridge Health Alliance

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CHA-IRB-0048/04/04

Identifier Type: -

Identifier Source: org_study_id

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