Could a common antidepressant ease rett syndrome?

NCT ID NCT07430046

Recruiting now Disease control Sponsor: University of Trieste Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether mirtazapine, an antidepressant, can improve mood, sleep, and motor symptoms in people with Rett syndrome. The study will enroll 54 females aged 5 to 40 with a confirmed MECP2 mutation. Participants will receive increasing doses of mirtazapine over six months, and researchers will monitor safety and symptom changes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: mirtazapine (an antidepressant)
What this could lead to: If it works, this could point toward a treatment to improve mood, sleep, and hand control in people with Rett syndrome.
What could go wrong: This is an early, small, open-label trial with no placebo group, so results may be less reliable. It is not a cure and may not work for everyone.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Neurologic Manifestations Rett syndrome sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RETT SYNDROME WITH PROVEN MECP2 MUTATION

Contacts and locations

Locations

Centro Epilessia - Unità Neurologia Pediatrica, ASST Ospedale Santi Carlo Paolo - Dipartimento Scienze della Salute, Università di Milano
RECRUITING

Milan, 20142, Italy
UOC di Neuropsichiatria Infantile, Policlinico Universitario "Gaetano Martino" di Messina, University of Messina. Messina
RECRUITING

Messina, 98125, Italy
Unità di Neuropsichiatria Infantile, IRCCS, Istituto Giannina Gaslini, Genova
RECRUITING

Genova, 16147, Italy
Unità di Pediatria, Dipartimento della Donna e dei Bambini - Policlinico S. M. alle Scotte. Siena
RECRUITING

Siena, 53100, Italy

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