Management of Catatonic Features in Adolescents With Profound Autism

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.

Conditions

• Autism Spectrum Disorder
• Catatonia

Interventions

DRUG

Intranasal Midazolam (Benzodiazepine Challenge Test)

Administered as a challenge test to all participants in the intervention group using the 5 mg/mL injectable formulation. Dose: 0.2-0.3 mg/kg (max single dose 10 mg), repeatable in 5-15 minutes up to 0.5 mg/kg (max total 10 mg). Delivered intranasally (half dose per nostril) to assess response via Pediatric Catatonia Rating Scale at 30 minutes.

DRUG

Oral Clonazepam

Participants who show \>50% reduction in PCRS score after the midazolam challenge receive oral clonazepam drops. Treatment starts at 2 mg/day and is gradually titrated over 2 weeks up to a maximum of 6 mg/day (in 2-3 divided doses) according to clinical response and tolerability. Participants are maintained on the lowest effective and tolerated dose and followed for 3 months. Patients who fail to achieve or maintain ≥50% improvement after 1 month at maximum tolerated dose (up to 8 mg/day) are shifted to ECT.

DEVICE

Electroconvulsive Therapy (ECT)

Participants who do not respond to the benzodiazepine challenge (\>50% PCRS reduction) or who fail oral clonazepam after 1 month at maximum dose receive bilateral (bitemporal) electrode ECT under general anesthesia using a brief-pulse, computer-controlled ECT device. The initial intensive phase consists of sessions administered twice per week for 4 weeks. Participants who achieve ≥50% reduction in PCRS score proceed to a maintenance phase with sessions once per week for an additional 8 weeks (total treatment duration up to 12 weeks). Pre-ECT evaluation includes CBC, liver and renal function tests, thyroid profile, coagulation profile, ECG, and neuroimaging as clinically indicated.

OTHER

Standard Assessments and Monitoring

All participants undergo standardized assessments including psychiatric evaluation (DSM-5), medical examination, IQ testing (Stanford-Binet 5th Edition), Social Communication Questionnaire (SCQ), ADOS-2 (Module 1 or 2), PCRS (at baseline, 30 min post-challenge, and weeks 2, 4, 8, 12), and Aberrant Behavior Checklist (ABC) at baseline and weeks 2, 4, 8, 12. Side effects are actively monitored throughout the study.

Sponsors & Collaborators

• Tanta University

  lead OTHER

Principal Investigators

• Mohamed · Faculty of Medicine, Tanta University (or Tanta University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2026-08-31

Completion

2026-10-31

Countries

• Egypt

Study Locations