Study Stopped
The study was never approved by the IRB and the PI left the VA
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFebruary 21, 2020
February 1, 2020
Same day
August 19, 2014
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Deplin w Supplements
EXPERIMENTALdeplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
Deplin w placebo
PLACEBO COMPARATORdeplin 15mg daily plus Placebo A and Placebo B for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John D Dingell VA Medical Center
Detroit, Michigan, 48201-1916, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 22, 2014
Study Start
November 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
February 21, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
This study never received IRB approval and never enrolled any participants. ClinicalTrials.gov entry should be removed.