Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatme… (NCT04529226) | Clinical Trial Compass
UnknownPhase 2
Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
Spain75 participantsStarted 2020-11-26
Plain-language summary
This clinical trial will prove whether a large number of people with intellectual disability and treatment-resistant psychosis could benefit from the use of clozapine. Benefit will mean a measurable significant improvement in subjects' clinical response and quality of life.
Who can participate
Age range16 Years – 55 Years
SexALL
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Inclusion Criteria:
* Subjects aged between 16 and 55 years
* Diagnosis of intellectual disability according to the Diagnostic and Statistical Manual of Mental Disorders Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (confirmed by a Intelligence Quotient (IQ) Score between 35 and 70 in the Kaufman test)
* Diagnosis of psychosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (confirmed by clinical interview).
* Treatment Resistant to antipsychotic drugs except clozapine.
* Behavioural disturbances and self-injurious behaviour over the last 6 months.
* Written informed consent of patients or legal representative.
* Negative pregnancy test (if apply)
Exclusion Criteria:
* Leukocytes \< 3500/mm3 and neutrophils \< 2000/mm3.
* Hypersensitivity to clozapine or excipients.
* Myeloproliferative disorders
* Uncontrolled epilepsy in the last 2 years.
* Paralytic ileus in the last 3 months.
* Diagnosis of an autism spectrum disorder
* Pregnancy and breastfeeding
* Any diseases with clozapine contraindicated.
* Any uncontrolled serious condition
* Need of treatment with more than one antipsychotic drug or electroconvulsive therapy
* Treatment with quinolones, drugs that cause agranulocytosis or drugs that affect the cytochrome P-450 enzymes.
* Risk of suicide based on the Columbia-Suicide Severity Rating Scale
What they're measuring
1
Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score.
Timeframe: Baseline and 12 Months
Trial details
NCT IDNCT04529226
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla