Management of Catatonic Features in Adolescents With Profound Autism

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Pediatric Catatonia Rating Scale (PCRS) score from baseline to week 12 — 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)
  Severity of catatonic symptoms as measured by the Pediatric Catatonia Rating Scale (PCRS), a modified version of the Bush-Francis Catatonia Rating Scale adapted for use in children and adolescents. The PCRS is a clinician-rated scale with up to 23 items (maximum total score = 60), assessing psychomotor disturbances including stupor, mutism, posturing, negativism, withdrawal, excitement, stereotypy, mannerisms, echolalia, echopraxia, and additional pediatric-specific items(e.g.,refusal to eat/drink, social withdrawal, incontinence, acrocyanosis, schizophasia, automatic compulsive movements). Higher scores indicate greater severity of catatonia. Mean change in total PCRS score from baseline (pre-intervention) to week 12. The PCRS is the primary efficacy measure of catatonic symptom severity. A ≥50% reduction from baseline is predefined as clinical response. between 30 to 50 % reduction from baseline is partial response. less than 30% reduction from baseline is predefined as non response

Trial sites (1)

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