Management of Catatonic Features in Adolescents With Profound Autism

NCT07498387 | Active Not Recruiting

• 1 other identifier: 36265MD157/10/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

profound autism; catatonia; autism spectrum disoder; Adolescent Psychiatry; Neurodevelopmental Disorders; Benzodiazepines; Midazolam; Clonazepam; Electroconvulsive Therapy; open label pilot study

Outcome Measures

Primary Outcomes (1)

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

  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

  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)

Secondary Outcomes (4)

• Change in Aberrant Behavior Checklist (ABC) Score

  Baseline, Week 2, Week 4, Week 8, and Week 12 (end of 3-month follow-up)

• Response rate to benzodiazepine challenge test

  30 minutes post-challenge (single time point)

• Proportion of participants requiring electroconvulsive therapy (ECT)

  Up to week 4 (decision point for ECT initiation)

• Incidence of adverse events

  Baseline through week 12 (continuous monitoring)

Study Arms (1)

Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study

EXPERIMENTAL

Adolescents aged 10-19 with profound autism and catatonic features, screened positive on the Pediatric Catatonia Rating Scale, and with recent severe challenging behaviors unresponsive to prior treatments. All participants undergo a benzodiazepine challenge test with intranasal midazolam. Responders (≥50% symptom improvement) receive oral clonazepam maintenance. Non-responders receive electroconvulsive therapy (ECT). Follow-up assessments occur every two weeks for 3 months using the Pediatric Catatonia Rating Scale (primary) and Aberrant Behavior Checklist (secondary). No control or comparator arm is included.

Drug: Intranasal Midazolam (Benzodiazepine Challenge Test); Drug: Oral Clonazepam; Device: Electroconvulsive Therapy (ECT); Other: Standard Assessments and Monitoring

Interventions

Intranasal Midazolam (Benzodiazepine Challenge Test) DRUG

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.

Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study

Oral Clonazepam DRUG

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.

Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study

Electroconvulsive Therapy (ECT) DEVICE

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.

Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study

Standard Assessments and Monitoring OTHER

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.

Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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):
• Screens positive for catatonic features on the Pediatric Catatonia Rating Scale (PCRS; modified Bush-Francis Catatonia Rating Scale for children and adolescents).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Child and Adolescent Psychiatry Clinics, Psychiatry and Neurology Center, Tanta University

Tanta, El-Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Catatonia; Neurodevelopmental Disorders

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohamed

  Faculty of Medicine, Tanta University (or Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. No masking is used, as all participants, caregivers, and treating clinicians are aware of the interventions administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of psychiatry in neuropsychiatry department

Model Details: Participants with profound autism will be screened for catatonic features. Those who meet criteria for catatonia will enter a single treatment pathway and receive a benzodiazepine challenge test. Participants who demonstrate clinical improvement will continue benzodiazepine treatment, while those who do not respond will receive electroconvulsive therapy. All participants are followed prospectively without randomization or a comparison group.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)