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

Depression Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02223299
• Other study ID #: 553Schanzer0002
• Status: Withdrawn
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2020
• Source: John D. Dingell VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

**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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• L-tyrosine
6g/d daily for 30 days
• 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
• Placebo B
a sugar-pill that looks like a real medication

Locations

Country	Name	City	State
United States	John D Dingell VA Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
John D. Dingell VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit of nutritional supplement	Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.	30 days