Antipsychotic Drug- ToxicityNCT06125275
Pattern of Acute Antipsychotic Drug- Toxicity in Children
An observational study of Antipsychotic Drug- Toxicity, run by Assiut University.
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.
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.
- Conditions
- Antipsychotic Drug- Toxicity
- Keywords
- Antipsychotic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 Nov 2023
- Study start30 Oct 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antipsychotic Drug- ToxicityStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ramadan Hussein Mohamed, Assiut University
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 32527281Gummin 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 29185815Evoy 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06125275
- Acronym / sponsor ID
- Antipsychotic Drug- Toxicity
- Conditions
- Antipsychotic Drug- Toxicity
- Keywords
- Antipsychotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- atients with history of exposure to antipsychotic drugs aged from 1month to 18 years old, who presented to emergency department
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- neonates less than one month .
- History of chronic exposure.
- Food poisoning and other poisonous.
- Other drugs toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Estimate prevalence of acute antipsychotics drug-toxicity in children and adolescents at AUCH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 32527281Berta 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.
- Background: PubMed 29185815Gummin 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.
- Background: PubMed 34396549Evoy 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.
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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.
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.