Trial · NCT07498387
Management of Catatonic Features in Adolescents With Profound Autism
NCT07498387, Not applicable, Active not recruiting, Tanta University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Management of Catatonic Features in Adolescents With Profound Autism. Trials, record NCT07498387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07498387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Management of Catatonic Features in Adolescents With Profound Autism
- NCT number
- NCT07498387
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- Tanta University
- Conditions
- Autism Spectrum Disorder, Catatonia
- Interventions
- Intranasal Midazolam (Benzodiazepine Challenge Test), Oral Clonazepam, Electroconvulsive Therapy (ECT), Standard Assessments and Monitoring
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Secondary | Change in Aberrant Behavior Checklist (ABC) Score | Baseline, Week 2, Week 4, Week 8, and Week 12 (end of 3-month follow-up) | 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 |
| Secondary | Response rate to benzodiazepine challenge test | 30 minutes post-challenge (single time point) | 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. |
| Secondary | Proportion of participants requiring electroconvulsive therapy (ECT) | Up to week 4 (decision point for ECT initiation) | 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. |
| Secondary | Incidence of adverse events | Baseline through week 12 (continuous monitoring) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07498387
GET https://conductscience.org/api/trials/v1/NCT07498387/registered