Active — Not RecruitingNot Applicable

Management of Catatonic Features in Adolescents With Profound Autism

Egypt30 participantsStarted 2026-01-01

Plain-language summary

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.

Who can participate

Age range

10 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 benzodiazepin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pediatric Catatonia Rating Scale (PCRS) score from baseline to week 12

Timeframe: Baseline, immediately post-benzodiazepine challenge (30 minutes after midazolam administration), Week 2, Week 4 , Week 8, and Week 12 (end of 3-month follow-up)

Trial details

NCT IDNCT07498387

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Autism Spectrum Disorder trials