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

February 19, 2020 updated by: John D. Dingell VA Medical Center

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

**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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201-1916
        • John D Dingell VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefit of nutritional supplement
Time Frame: 30 days
Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John D. Dingell VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 553Schanzer0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

This study never received IRB approval and never enrolled any participants. ClinicalTrials.gov entry should be removed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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