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

Recruiting

• Conditions: Bipolar Depression; Depressive Disorder; Bipolar Disorder

• Registration Number: NCT06369792
• Lead Sponsor: Les Toises - Psychiatry and Psychotherapy Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psychiatric symptomatology	At baseline, 1,2,4,8 weeks	self- and hetero-questionnaire psychiatric scales
EDIT-B profiling	At baseline, 1,2,4,8 weeks	Measurement of RNA editing over time

Trial Locations

Locations (1)

Les Toises - Psychiatry and Psychotherapy Center; 🇨🇭 Lausanne, Switzerland