Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.

Sponsor

John D. Dingell VA Medical Center (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT02223299

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

This study never received IRB approval and no participants were ever enrolled The purpose of this study is to determine if adding over the counter nutritional supplements will have a benefit to participants currently taking prescribed antidepressants who have not experienced complete remission of their depression symptoms.

Condition or Disease	Intervention/Treatment	Phase
Depression	Dietary Supplement: L-tyrosine Dietary Supplement: L-Tryptophan Drug: deplin Other: Placebo A Other: Placebo B	N/A

Detailed Description

Inclusion Criteria:

Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms as defined by "feeling their normal selves"

Randomized into two groups:

Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses, and L-tryptophan 2g/d into 2 divided doses.

Control: will receive month supply of deplin 15mg , and 2 placebo pills.

Beck Depression Scale (BDI-2) to be administered at baseline and every 2 weeks for 1 month.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

A Randomized Double-Blind Placebo-Controlled Pilot Study of L-tyrosine and L-tryptophan in Depressed Patients Receiving L-methylfolate and and SSRI

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deplin w Supplements deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days	Dietary Supplement: L-tyrosine 6g/d daily for 30 days Dietary Supplement: L-Tryptophan 2g/d daily for 30 days Drug: deplin 15mg daily for 30 days Other Names: L-methylfolate
Placebo Comparator: Deplin w placebo deplin 15mg daily plus Placebo A and Placebo B for 30 days	Drug: deplin 15mg daily for 30 days Other Names: L-methylfolate Other: Placebo A a sugar-pill that looks like a real medication Other: Placebo B a sugar-pill that looks like a real medication

Arm

Intervention/Treatment

Experimental: Deplin w Supplements

deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days

Dietary Supplement: L-tyrosine

6g/d daily for 30 days

Dietary Supplement: L-Tryptophan

2g/d daily for 30 days

Drug: deplin

15mg daily for 30 days

Other Names:

L-methylfolate

Placebo Comparator: Deplin w placebo

deplin 15mg daily plus Placebo A and Placebo B for 30 days

Drug: deplin

15mg daily for 30 days

Other Names:

L-methylfolate

Other: Placebo A

a sugar-pill that looks like a real medication

Other: Placebo B

a sugar-pill that looks like a real medication

Outcome Measures

Primary Outcome Measures

Benefit of nutritional supplement [30 days]
Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

This study never received IRB approval and no participants were enrolled

Inclusion Criteria:

Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms.