Back to resultsPilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.
Primary Purpose
Depression
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-tyrosine
L-Tryptophan
deplin
Placebo A
Placebo B
Sponsored by
About this trial
This is an interventional other trial for Depression focused on measuring Depression, SSRI, Nutritional Supplements, Beck Depression Scale
Eligibility 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.
Sites / Locations
- John D Dingell VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Deplin w Supplements
Deplin w placebo
Arm Description
deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
deplin 15mg daily plus Placebo A and Placebo B for 30 days
Outcomes
Primary Outcome Measures
Benefit of nutritional supplement
Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT02223299
First Posted
August 19, 2014
Last Updated
February 19, 2020
Sponsor
John D. Dingell VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02223299
Brief Title
Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never approved by the IRB and the PI left the VA
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John D. Dingell VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, SSRI, Nutritional Supplements, Beck Depression Scale
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deplin w Supplements
Arm Type
Experimental
Arm Description
deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
Arm Title
Deplin w placebo
Arm Type
Placebo Comparator
Arm Description
deplin 15mg daily plus Placebo A and Placebo B for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
L-tyrosine
Intervention Description
6g/d daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Tryptophan
Intervention Description
2g/d daily for 30 days
Intervention Type
Drug
Intervention Name(s)
deplin
Other Intervention Name(s)
L-methylfolate
Intervention Description
15mg daily for 30 days
Intervention Type
Other
Intervention Name(s)
Placebo A
Intervention Description
a sugar-pill that looks like a real medication
Intervention Type
Other
Intervention Name(s)
Placebo B
Intervention Description
a sugar-pill that looks like a real medication
Primary Outcome Measure Information:
Title
Benefit of nutritional supplement
Description
Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
John D Dingell VA Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1916
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study never received IRB approval and never enrolled any participants. ClinicalTrials.gov entry should be removed.
Learn more about this trial
Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.
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