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NCT06369792 Clinical Trial

PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION

Bipolar Disorder Clinical Trial

Official title:
EVALUATION PROSPECTIVE DE L'AIDE AU DIAGNOSTIC ET AU TRAITEMENT PAR BIOMARQUEURS SANGUINS CHEZ DES PATIENTS DRUG-NAÏFS AMBULATOIRES SOUFFRANT DE DEPRESSION

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06369792
Other study ID # 2020-00266
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2020
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source Les Toises - Psychiatry and Psychotherapy Center
Contact Aurélie Reymond-Delacrétaz, PhD
Phone 0041 584-580-580
Email aurelie.delacretaz@lestoises.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult drug-naïve outpatients suffering from depression and/or bipolar disorders who start a pharmacological treatment with escitalopram, fluoxetine, sertraline or quetiapine and who gave his written informed consent to participate in the present study. Exclusion Criteria: - Any patient without capacity of discernment or with harmful use of psychoactive substances

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Les Toises - Psychiatry and Psychotherapy Center Lausanne

Sponsors (1)
Lead Sponsor Collaborator
Les Toises - Psychiatry and Psychotherapy Center

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary psychiatric symptomatology self- and hetero-questionnaire psychiatric scales At baseline, 1,2,4,8 weeks
Primary EDIT-B profiling Measurement of RNA editing over time At baseline, 1,2,4,8 weeks
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