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

John D. Dingell VA Medical Center

Status: Withdrawn

Conditions: Depression

Treatments: Dietary Supplement: L-Tryptophan; Dietary Supplement: L-tyrosine; Other: Placebo B; Drug: deplin; Other: Placebo A

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02223299

553Schanzer0002

Details and patient eligibility

About

**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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Deplin w Supplements

Experimental group

Description:

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

Treatment:

Drug: deplin

Dietary Supplement: L-Tryptophan

Dietary Supplement: L-tyrosine

Deplin w placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo B

Drug: deplin

Other: Placebo A