Predicting how well antidepressants will work based on motivation assessment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the mechanisms of action of antidepressants by assessing motivation deficits in patients with major depressive disorder. One hundred participants will be enrolled and randomized to receive either escitalopram or vortioxetine, with their responses monitored through a series of evaluations over one year. The study employs neurocomputational modeling and functional MRI to identify brain correlates of motivation before and during treatment. Additionally, 36 healthy volunteers will be included for comparative analysis.

Why it matters

Who can join: the full rules

Patients with major depressive disorder

Inclusion Criteria:

* Meeting DSM-5 criteria for major depressive disorder (single or recurrent episodes)
* With a MADRS score \>= 24
* For which a new line of treatment is needed
* No previous line of antidepressant for this episode or wash-out long-enough to avoid carry-over effects
* Valid health care insurance

Exclusion Criteria:

* Treatment-resistant depression (defined as insufficient response despite at least 2 trials of antidepressant prescribed at adequate dose and duration)
* Subjects with a trial of escitalopram and/or vortioxetine for the current episode, or with contra-indication to one of these two drugs
* Subjects with a diagnostic of persistent depressive disorder, bipolar disorder or schizophrenia, neurodeveloppemental disorder, unremitted substance abuse disorder other than tobacco, personality disorder severe enough to compromise the follow-up (based on investigator's appreciation).
* Subject with a history of neurological disorder: parkinson's disease, dementia
* Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants
* Pregnant or breastfeeding women
* involuntary hospitalisation and legal protection measures

Healthy volunteers

Inclusion Criteria:

\- Valid health care insurance

Exclusion Criteria:

* Subjects with a diagnostic of persistent depressive disorder, bipolar disorder or schizophrenia, neurodeveloppemental disorder, unremitted substance abuse disorder other than tobacco, personality disorder severe enough to compromise the follow-up (based on investigator's appreciation).
* Subject with a history of neurological disorder: parkinson's disease, dementia
* Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants
* Pregnant or breastfeeding women

Where it's running

• - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
  Paris, France Recruiting
• Groupe hospitalo-universitaire de Grenoble Alpes
  La Tronche, Isère, France Not yet recruiting
• Centre hospitalier Universitaire de Lille
  Lille, Nord, France Not yet recruiting
• Centre hospitalier Universitaire de Saint-Etienne
  Saint-Priest-en-Jarez, Pays de la Loire Region, France Not yet recruiting
• Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Fabien Vinckier
• Email: f.vinckier@ghu-paris.fr
• Phone: 0033683714083

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.