NCT07498387Active, not recruiting
Management of Catatonic Features in Adolescents With Profound Autism
Management of Catatonic Features in Adolescents With Profound Autism: A Prospective Uncontrolled Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if benzodiazepines and ECT can treat Catatonic features in Adolescents with Autistic spectrum disorder, it will also learn about Safety and efficacy of benzodiazepines and ECT. the main questions it aim to answer is if adolescents with profound Autism presenting with catatonic features will show significant improvement on treatment with either benzodiazepines or ECT with no major side effects. it is an open label pilot study whose participants diagnosed with profound autism presenting with catatonia will receive loading midazolam then maintenance clonazepam daily / ECT sets will be followed up every 2 weeks in 1st month then once / month for next 2 months, observation of symptom improvement will be tracked. Clinical outcomes will be assessed using the Pediatric Catatonia Rating Scale as the primary outcome measure and the Aberrant Behavior Checklist as a secondary outcome measure. Participants will be followed for three months to evaluate treatment response and safety.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 5 Feb 2026
- Start date
- Jan 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Tanta University
- Diseases
- Autism
- NCT number
- NCT07498387
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From Jan 2026 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Current participation in another interventional clinical trial.
- Caregiver/guardian unwilling or unable to provide informed consent or comply with study procedures.
Who the study is looking for
- 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).
Age in the registry: 10 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Child and Adolescent Psychiatry Clinics, Psychiatry and Neurology Center, Tanta University Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.