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Antipsychotic Drug- ToxicityNCT06125275

Pattern of Acute Antipsychotic Drug- Toxicity in Children

An observational study of Antipsychotic Drug- Toxicity, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital. Determine the pattern and outcome of acute antipsychotic drug- toxicity of children who are admitted to The emergency department of Assiut University Children Hospital (AUCH). Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Antipsychotic Drug- Toxicity
How many people
50 participants
Where
No sites listed yet
Study dates
30 Oct 2023to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

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 1 month to 18 years
  • All sexes
  • Child, Adult

Study population: atients with history of exposure to antipsychotic drugs aged from 1month to 18 years old, who presented to emergency department

Who may be able to join

  • Patients with history of exposure to antipsychotic drugs aged from 1month to 18 years old, who presented to emergency department.
  • Both sexes.
  • Diagnosis is according to clinical features suggestive of possible antipsychotic drug- toxicity.

Who cannot join

  • neonates less than one month .
  • History of chronic exposure.
  • Food poisoning and other poisonous.
  • Other drugs toxicity.

Trial locations and contacts

No sites are listed yet.

Esraa RamadanHussein contact

01119865078

esraaramadan249@gmail.com

Khalaf Abd El-Aal Sayed contact

01010571490

Khalaf13013@aun.edu.eg

About this study

Official title: Pattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital

Pattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital.

  • Determine the pattern and outcome of acute antipsychotic drug- toxicity of children who are admitted to The emergency department of Assiut University Children Hospital (AUCH).
  • Estimate prevalence of acute antipsychotics drug-toxicity in children and adolescents at AUCH.
Read the detailed description

Acute poisoning in pediatrics is very common as it is one of the prominent causes of mortality and morbidity worldwide as, children are curious and they explore at home and around. Acute poisoning has also been the 3rd most common treated injury for children less than 16 years in the emergency units. Accidental ingestion is one of the most important causes of poisoning in children and is most prevalent between 1-5 year olds. During adolescence, medications used for committing suicide are the main cause of poisoning.

Drug ingestion is the commonest cause of acute poisoning among children according to poison control centers records all over the world. A great percent of hospital admission cases involves drug poisoning, particularly with psychotropic drugs such as sedatives, antidepressants, and neuroleptics.

Antipsychotics are primary used to treat agitated behavior , various neurological conditions (motor tics ,chorea and dystonia),schizophrenia, manic phase of bipolar disorders; however they are often used to treat nausea, vomiting and headache. Antipsychotics toxic effects include anticholinergic and extrapyramidal syndromes as well as CNS and cardiovascular depression.

Antipsychotics are classified as ""typical"" or ""atypical."" They are also classified by their chemical structure as first-generation, including butyrophenones (droperidol, haloperidol) and phenothiazines (chlorpromazine, promethazine), and second generation such as olanzapine, risperidone, quetiapine, and more recently ziprasidone and aripiprazole.

Second-generation antipsychotics, or ''atypical antipsychotics,'' were introduced in 1989 and were anticipated to be equally effective for treatment of psychosis.They also had the advertised advantage of fewer extrapyramidal side effects such as dystonias, akathisia, parkinsonism, and tardive dyskinesia, at therapeutic dosing.

These medications are now first-line therapy in the treatment of schizophrenia and are additionally being used in a wide array of conditions in both adults and children, including bipolar disorder, tic disorders, eating disorders, obsessive-compulsive disorder, and developmental disorders such as autism. Risperidone and aripiprazole were approved by the FDA in 2006 and 2009, respectively, to treat irritability associated with Autism spectrum disorder (ASD).

Antipsychotics overdose is common in Western society. In 2010, poison control centers in the US received about 43 000 calls complaining of atypical antipsychotics overdose. The actual incidence of atypical antipsychotics overdose is greater than announced, due to underreporting. Overdose of an atypical antipsychotic is presented clinically with multiple disorders as CNS depression, tachycardia and orthostatic hypotension.

Supportive measures as maintaining patent airway, assessment of breathing, maintaining adequate circulation are necessary before confirmation of intoxication. Evaluation and management of antipsychotic drugs toxicities needs high level of suspicion, careful history taking, proper examination, and investigations to improve the outcome of such patients.

Keywords
Antipsychotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the pattern and outcome of acute antipsychotic drug- toxicity of children who are admitted to The emergency department of Assiut University Children Hospital (AUCH).

    Estimate prevalence of acute antipsychotics drug-toxicity in children and adolescents at AUCH

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start30 Oct 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06125275
Sponsor's protocol ID
Antipsychotic Drug- Toxicity
Status last verified
Nov 2023
First submitted
6 Nov 2023
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Berta GN, Di Scipio F, Bosetti FM, Mognetti B, Romano F, Carere ME, Del Giudice AC, Castagno E, Bondone C, Urbino AF. Childhood acute poisoning in the Italian North-West area: a six-year retrospective study. Ital J Pediatr. 2020 Jun 11;46(1):83. doi: 10.1186/s13052-020-00845-0.

    PubMed 32527281
  • Gummin DD, Mowry JB, Spyker DA, Brooks DE, Fraser MO, Banner W. 2016 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 34th Annual Report. Clin Toxicol (Phila). 2017 Dec;55(10):1072-1252. doi: 10.1080/15563650.2017.1388087. Epub 2017 Nov 29.

    PubMed 29185815
  • Evoy KE, Peckham AM, Covvey JR, Tidgewell KJ. Gabapentinoid Pharmacology in the Context of Emerging Misuse Liability. J Clin Pharmacol. 2021 Aug;61 Suppl 2:S89-S99. doi: 10.1002/jcph.1833.

    PubMed 34396549

Questions about this trial

What is this clinical trial studying?

An observational study of Antipsychotic Drug- Toxicity, run by Assiut University.

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 3 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esraa RamadanHussein (01119865078, esraaramadan249@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the pattern and outcome of acute antipsychotic drug- toxicity of children who are admitted to The emergency department of Assiut University Children Hospital (AUCH). (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06125275, which also lists 3 linked publications.

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 9 Nov 2023.

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