Pharmacogenetic and Antidepressant Treatment in Elderly | NCT02856477

Studies
Pharmacogenetic and Antidepressant Treatment in Elderly

NCT02856477

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Terminated

Last Update Posted

Aug 5, 2016Estimated

Enrollment

28Actual

Phase

Not Applicable

Conditions

Depression

Interventions

urine analysis

Countries

France

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 4, 2016Estimated

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

Aug 4, 2016

Last Update Posted Date

Aug 5, 2016Estimated

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

The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.

Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.

Detailed Description

Not provided

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adapted treatment	Experimental	the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis	Biological: urine analysis
non-adaptated treatment	Experimental	the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis	Biological: urine analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urine analysis	Biological	a sample of urine is collected during 8 hours.	adapted treatment non-adaptated treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient remission	remission is defined by a Montgomery and asberg depression rating (MADRS) score<10.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current major depressive disorder
antidepressant treatment

Exclusion Criteria:

dextromethorphan contra-indication
other psychiatric disorder
kidney failure
liver failure mini mental State Examination (MMSE)<18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
pierre Vandel, MD PhD	Centre Hospitalier Universitaire de Besancon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besancon		Besançon	Doubs	25030	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016482	Urinalysis

Ancestor Terms

ID	Term
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided