Autism Spectrum DisorderMOCFAPANCT07498387
Management of Catatonic Features in Adolescents With Profound Autism
A study testing Intranasal Midazolam (Benzodiazepine Challenge Test), Oral Clonazepam and Electroconvulsive Therapy (ECT) in people with Autism Spectrum Disorder and Catatonia, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Autism Spectrum Disorder, Catatonia
- What is being tested?
- Intranasal Midazolam (Benzodiazepine Challenge Test), Oral Clonazepam and Electroconvulsive Therapy (ECT)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Child and Adolescent Psychiatry Clinics, Psychiatry and Neurology Center, Tanta University
Tanta, El-Gharbia Governorate, 31527
About this study
Official title: Management of Catatonic Features in Adolescents With Profound Autism: A Prospective Uncontrolled Trial
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.
Read more
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.
Read the 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
- Being tested
- Intranasal Midazolam (Benzodiazepine Challenge Test), Oral Clonazepam, Electroconvulsive Therapy (ECT), Standard Assessments and Monitoring
- Keywords
- profound autism, catatonia, autism spectrum disoder, Adolescent Psychiatry, Neurodevelopmental Disorders, Benzodiazepines, Midazolam, Clonazepam, Electroconvulsive Therapy, open label pilot study
- Medical subject headings
- Autism Spectrum Disorder, Catatonia, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Oral ClonazepamDrug
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)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.
Standard Assessments and MonitoringOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intranasal Midazolam (Benzodiazepine Challenge Test); Drug: Oral Clonazepam; Device: Electroconvulsive Therapy (ECT); Other: Standard Assessments and Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
he Aberrant Behavior Checklist (ABC) is a caregiver-rated instrument designed to assess problem behaviors in individuals with developmental disabilities, including those with autism spectrum disorder. It consists of 58 items rated on a 4-point scale (0 = not at all a problem to 3 = problem is severe), yielding five subscale scores: Irritability, Agitation, Crying (15 items) Lethargy/Social Withdrawal (16 items) Stereotypic Behavior (7 items) Hyperactivity/Noncompliance (16 items) Inappropriate Speech (4 items) Higher subscale and total scores indicate greater severity of aberrant behaviors. In this study, the ABC (Community version or equivalent adapted for caregiver report) will be used to evaluate broader behavioral improvements, including challenging behaviors such as irritability, aggression, self-injury, and social withdrawal, which are common in profound autism with catatonic features. An Arabic-translated version (with author permission obtained) will be administered. This se
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12 (end of 3-month follow-up)
Response rate to benzodiazepine challenge test
Proportion of participants showing >50% reduction in PCRS total score 30 minutes after intranasal midazolam challenge (0.15 mg/kg, max 10 mg). Positive response defines benzodiazepine responders who continue on oral clonazepam; negative response leads to ECT pathway.
Measured: 30 minutes post-challenge (single time point)
Proportion of participants requiring electroconvulsive therapy (ECT)
Percentage of participants who fail the benzodiazepine challenge (>50% PCRS reduction) or who fail to maintain ≥50% PCRS improvement after 1 month of maximum-dose oral clonazepam (up to 8 mg/day) and are therefore shifted to bilateral bitemporal ECT.
Measured: Up to week 4 (decision point for ECT initiation)
Incidence of adverse events
Frequency and severity of all adverse events (including sedation, hypotension, and any other treatment-related events) occurring during benzodiazepine challenge, oral clonazepam titration/maintenance, or ECT sessions. Events are actively monitored and recorded at every study visit and during ECT procedures.
Measured: Baseline through week 12 (continuous monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2026
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toka Khaled Talaat, Tanta University
- Investigators
- Mohamed, Principal investigator, Faculty of Medicine, Tanta University (or Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498387
- Sponsor's protocol ID
- 36265MD157/10/23
- Acronym
- MOCFAPA
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD). This is a small, single-site open label pilot study conducted as part of an MD thesis at Tanta University, Egypt, involving a vulnerable population of adolescents with profound autism and catatonia. Due to privacy concerns, small sample size, potential for re-identification, and absence of a dedicated secure data repository or funding for de-identification and controlled access, IPD will not be made available to other researchers. Aggregate results will be published in scientific journals and/or a thesis, and summary data may be shared upon reasonable request to the principal investigator after publication, subject to ethics committee approval and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Catatonic Features in Adolescents With Profound Autism: A Prospective Uncontrolled Trial
- ClinicalTrials.gov ID
- NCT07498387
- Acronym / sponsor ID
- MOCFAPA / 36265MD157/10/23
- Conditions
- Autism Spectrum Disorder, Catatonia
- Keywords
- profound autism, catatonia, autism spectrum disoder, Adolescent Psychiatry, Neurodevelopmental Disorders, Benzodiazepines, Midazolam, Clonazepam
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study | Experimental | Drug: Intranasal Midazolam (Benzodiazepine Challenge Test), Drug: Oral Clonazepam, Device: Electroconvulsive Therapy (ECT), Other: Standard Assessments and MonitoringAdolescents 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study |
| Oral ClonazepamParticipants 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. | Drug | Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study |
| 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. | Device | Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study |
| Standard Assessments and MonitoringAll 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. | Other | Adolescents with Profound Autism and Catatonia, Open-label single-arm interventional pilot study |
Primary outcome
Change in Pediatric Catatonia Rating Scale (PCRS) score from baseline to week 12
Time frame: 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
4 secondary outcomes
Change in Aberrant Behavior Checklist (ABC) Score
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12 (end of 3-month follow-up)
Response rate to benzodiazepine challenge test
Time frame: 30 minutes post-challenge (single time point)
Proportion of participants requiring electroconvulsive therapy (ECT)
Time frame: Up to week 4 (decision point for ECT initiation)
Incidence of adverse events
Time frame: Baseline through week 12 (continuous monitoring)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD). This is a small, single-site open label pilot study conducted as part of an MD thesis at Tanta University, Egypt, involving a vulnerable population of adolescents with profound autism and catatonia. Due to privacy concerns, small sample size, potential for re-identification, and absence of a dedicated secure data repository or funding for de-identification and controlled access, IPD will not be made available to other researchers. Aggregate results will be published in scientific journals and/or a thesis, and summary data may be shared upon reasonable request to the principal investigator after publication, subject to ethics committee approval and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed principal investigator
Faculty of Medicine, Tanta University (or Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Midazolam (Benzodiazepine Challenge Test), Oral Clonazepam and Electroconvulsive Therapy (ECT) in people with Autism Spectrum Disorder and Catatonia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Catatonia Rating Scale (PCRS) score from baseline to week 12 (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.