Pilot Study: Combining Nutritional Supplements With Stand... | NCT02223299

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

NCT02223299

Sponsor

John D. Dingell VA Medical Center

Status

Withdrawn

Last Update Posted

Feb 21, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Depression

Interventions

L-tyrosine
L-Tryptophan
deplin
Placebo A
Placebo B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was never approved by the IRB and the PI left the VA

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Aug 19, 2014

First Submission Date that Met QC Criteria

Aug 21, 2014

First Posted Date

Aug 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deplin w Supplements	Experimental	deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days	Dietary Supplement: L-tyrosine Dietary Supplement: L-Tryptophan Drug: deplin
Deplin w placebo	Placebo Comparator	deplin 15mg daily plus Placebo A and Placebo B for 30 days	Drug: deplin Other: Placebo A Other: Placebo B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-tyrosine	Dietary Supplement	6g/d daily for 30 days	Deplin w Supplements

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John D Dingell VA Medical Center		Detroit	Michigan	48201-1916	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D014443	Tyrosine
D014364	Tryptophan
C005984	5-methyltetrahydrofolate

Ancestor Terms

ID	Term
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided