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

April 12, 2024 updated by: Les Toises - Psychiatry and Psychotherapy Center

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1005
        • Recruiting
        • Les Toises - Psychiatry and Psychotherapy Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes drug-naïve adult outpatients (aged 18 or over) with depression (F32-33) and/or bipolar disorder (F30-F31) who start escitalopram, fluoxetine, sertraline or quetiapine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Les Toises - Psychiatry and Psychotherapy Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00266

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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