Can a simple drug calm catatonia in autistic teens? new study hopes so
NCT ID NCT07498387
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether benzodiazepines (midazolam and clonazepam) and, if needed, electroconvulsive therapy (ECT) can safely reduce catatonic symptoms in 30 adolescents aged 10–19 with profound autism. Participants first receive a midazolam challenge; those who respond then take daily clonazepam for up to 3 months. The main goal is to see if symptoms improve significantly without major side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Midazolam and Clonazepam (benzodiazepines)
- What this could lead to
- If it works, this could point toward a safe, effective way to manage catatonic episodes in teens with profound autism, improving their daily functioning.
- What could go wrong
- This is a very small, early pilot study with only 30 participants and no control group, so results may not apply broadly. Benzodiazepines can cause sedation or dependence.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * For Screening Group (to identify profound autism and screen for catatonia): Adolescents aged 10 to 19 years (defined per WHO as the second decade of life). Diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria, with significant language impairment. Exceeds diagnostic threshold on the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Module 1 (for minimal or no speech) OR Module 2 (for phrase speech) AND estimated IQ below 50 on the Stanford-Binet Intelligence Scales, 5th Edition. For Intervention Group (those proceeding to benzodiazepine challenge ± ECT): Meets all screening group inclusion criteria. Recent history of severe challenging behaviors (e.g., agitation, aggression, self-injury) refractory to at least two trials of Applied Behavioral Analysis (ABA) AND at least one adequate trial of an antipsychotic medication approved for irritability in ASD (e.g., risperidone or aripiprazole, with sufficient dose and duration). Screens positive for catatonic features on the Pediatric Catatonia Rating Scale (PCRS; modified Bush-Francis Catatonia Rating Scale for children and adolescents). Exclusion Criteria: * Presence of any neurological or medical condition that could affect cognitive or behavioral functioning (e.g., encephalitis, other active neurological diseases, renal failure, hepatic impairment, thyroid disorders, diabetes mellitus, or other uncontrolled systemic illnesses). * Any contraindication to benzodiazepines (e.g., known hypersensitivity, severe respiratory depression risk) or ECT (e.g., unstable cardiac conditions, intracranial mass, recent stroke, or other standard medical contraindications to anesthesia/general anesthesia). * Current participation in another interventional clinical trial. * Caregiver/guardian unwilling or unable to provide informed consent or comply with study procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Child and Adolescent Psychiatry Clinics, Psychiatry and Neurology Center, Tanta University
Tanta, El-Gharbia Governorate, 31527, Egypt
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