Natural Supplements for Unipolar Depression

Cambridge Health Alliance

Status and phase: Completed; Phase 4

Conditions: Unipolar Depression

Treatments: Drug: Supplements of L-methionine, betaine and folate

Study type: Interventional

Funder types: Other

Identifiers

NCT00226356

CHA-IRB-0048/04/04

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supplements of L-methionine, betaine and folate

Experimental group

Treatment:

Drug: Supplements of L-methionine, betaine and folate