NCT02223299

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: John D. Dingell VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Depression

Interventions

Type	Name	Description
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	Placebo A	a sugar-pill that looks like a real medication
OTHER	Placebo B	a sugar-pill that looks like a real medication

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-08-22
• Last updated: 2020-02-21

Locations

1 site across 1 country: United States