NCT07498387

Management of Catatonic Features in Adolescents With Profound Autism

Management of Catatonic Features in Adolescents With Profound Autism: A Prospective Uncontrolled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition characterized by persistent impairments in social communication and interaction, along with restricted and repetitive patterns of behavior. A subgroup of individuals with ASD meets criteria for profound autism, defined by severe functional impairment requiring continuous supervision, very limited or absent language, and typically a significant intellectual disability (IQ \< 50). Adolescents with profound autism often present with severe challenging behaviors, including agitation, aggression, self-injury, and marked functional deterioration. Catatonia is a complex neuropsychiatric syndrome characterized by a range of psychomotor disturbances such as stupor, mutism, posturing, negativism, agitation, and stereotyped movements. Increasing evidence suggests that catatonia occurs with increased frequency in adolescents and young adults with ASD, particularly those with more severe functional impairment. Catatonic symptoms in individuals with autism may be under-recognized due to overlap with baseline autistic behaviors, leading to delays in diagnosis and treatment. This open label pilot study aims to explore the presence of catatonic features among Egyptian adolescents with profound autism and to evaluate the efficacy and safety of benzodiazepines and electroconvulsive therapy (ECT) in their management. The study will be conducted at the Psychiatry and Neurology Center, Tanta University Hospitals, Egypt. Adolescents aged 10 to 19 years with a diagnosis of profound autism attending child and adolescent psychiatry clinics will be screened for catatonic features during the study period. Diagnosis of ASD will be confirmed according to DSM-5 criteria, supported by standardized assessment using the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), along with documentation of intellectual disability using the Stanford-Binet Intelligence Scales (Fifth Edition). All eligible participants will undergo comprehensive psychiatric evaluation, medical examination, and standardized assessments, including the Pediatric Catatonia Rating Scale (PCRS) and the Aberrant Behavior Checklist (ABC). Participants who screen positive for catatonia on the PCRS and meet criteria for the intervention phase will be offered a benzodiazepine challenge test using intranasal midazolam. A positive benzodiazepine challenge is defined as a reduction of at least 50% in catatonic symptoms on the PCRS within 30 minutes of administration. Participants demonstrating a positive response will be treated with oral clonazepam at the lowest effective and tolerated dose and followed for three months, with assessments conducted every two weeks using the PCRS as the primary outcome measure and the ABC as a secondary outcome measure. Participants who do not show a sufficient response to benzodiazepines will be offered treatment with electroconvulsive therapy (ECT) following caregiver consent. ECT will be administered under general anesthesia using bilateral electrode placement and brief-pulse stimulation. The acute treatment course will consist of two sessions per week for four weeks, followed by continuation treatment once weekly for up to eight weeks in participants demonstrating clinical improvement. Clinical response will be defined as a reduction of at least 50% in PCRS scores. Follow-up assessments will continue biweekly for three months. Safety monitoring will be conducted throughout the study period, and any adverse events related to benzodiazepines or ECT will be documented. Written informed consent will be obtained from caregivers prior to participation, and all procedures will be conducted in accordance with ethical standards approved by the institutional ethics committee. This study represents the first investigation of catatonia in adolescents with profound autism in Egypt and the Arab world and aims to contribute to improved recognition and management of this underdiagnosed but treatable condition.

Conditions

• Autism Spectrum Disorder
• Catatonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Egypt