NCT02856477

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2007

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

8.4 years

First QC Date

August 2, 2016

Last Update Submit

August 4, 2016

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • patient remission

    remission is defined by a Montgomery and asberg depression rating (MADRS) score\<10.

    6 months

Study Arms (2)

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

urine analysisBIOLOGICAL

a sample of urine is collected during 8 hours.

adapted treatmentnon-adaptated treatment

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • current major depressive disorder
  • antidepressant treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, Doubs, 25030, France

Location

MeSH Terms

Conditions

Depression

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Study Officials

  • pierre Vandel, MD PhD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

November 1, 2007

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)