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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02856477
Other study ID # R/2007/32
Secondary ID
Status Terminated
Phase N/A
First received August 2, 2016
Last updated August 4, 2016
Start date November 2007
Est. completion date April 2016

Study information

Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Biological:
urine analysis
a sample of urine is collected during 8 hours.

Locations

Country Name City State
France CHU Besancon Besancon Doubs

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient remission remission is defined by a Montgomery and asberg depression rating (MADRS) score<10. 6 months No
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