tDCS for catatonic depression in Down syndrome

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 multicenter, randomized, double-blind, sham-controlled study will compare active versus sham bifrontal tDCS (2 mA for 20 minutes per session) over 15 sessions in 30 adults with Down syndrome and comorbid depressive symptoms with catatonia. Primary outcome is change in depressive and catatonic symptoms measured by the BFCRS from Day 0 to Day 5; secondary outcomes include safety, cognitive function, and exploratory EEG and biological markers. The trial aims to assess feasibility, tolerability, and short-term efficacy, with additional follow-ups at 1 and 3 months. Recruitment is at Hopital Vinatier in Lyon, France, with participants required to meet DSM-5 criteria for major depressive disorder with catatonia and have Down syndrome.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient with Down syndrome
* Age \> 18
* Diagnosis of Major Depressive Disorder MDD with catatonic symptoms according to the DSM-5 criteria
* Informed consent signed by the patient, by the patient under curatorship, or by the legal representative in the case of a patient under guardianship.
* Person affiliated to the French social security system or equivalent

Exclusion Criteria:

* Pregnancy (checked with a pregnancy test)
* Contraindication for tDCS(i.e., cochlear implant)
* Refusal of the patients or their legal representatives
* Other persons protected under the CSP (judicial safeguard, family habilitation)

Where it's running

• Hopital Vinatier
  Lyon, Auvergne-Rhône-Alpes, France Recruiting

Study contacts

• Principal investigator: CAROLINE C DEMILY, MD PhD HDR — Hopital Vinatier
• Study coordinator: JEROME J BRUNELIN, PhD, HDR)
• Email: jerome.brunelin@ch-le-vinatier.fr
• Phone: 00334 37 91 54 95

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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.