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

Study Overview
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Brief Summary
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**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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: L-tyrosine
* Dietary Supplement: L-Tryptophan
* Drug: deplin
* Other: Placebo A
* Other: Placebo B


Participation Criteria
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Eligibility Criteria
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**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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deplin w Supplements<br>deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days | Dietary Supplement: L-tyrosine<br>* 6g/d daily for 30 days<br>Dietary Supplement: L-Tryptophan<br>* 2g/d daily for 30 days<br>Drug: deplin<br>* 15mg daily for 30 days<br>* Other names: L-methylfolate;|
| Placebo Comparator: Deplin w placebo<br>deplin 15mg daily plus Placebo A and Placebo B for 30 days | Drug: deplin<br>* 15mg daily for 30 days<br>* Other names: L-methylfolate;Other: Placebo A<br>* a sugar-pill that looks like a real medication<br>Other: Placebo B<br>* a sugar-pill that looks like a real medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, SSRI, Nutritional Supplements, Beck Depression Scale