Status:
ACTIVE_NOT_RECRUITING
Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Psychosis
Intellectual Disability
Eligibility:
All Genders
16-55 years
Phase:
PHASE2
Brief 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 s...
Detailed Description
Randomized, open-label, multicenter phase II clinical trial that seeks to evaluate the safety and efficacy of clozapine versus standard clinical treatment in patients between the ages of 16 and 55 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04529226
Start Date
November 26 2020
End Date
December 30 2025
Last Update
March 20 2024
Active Locations (20)
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1
Unidad de Salud Mental Comunitaria Andújar
Andújar, Spain
2
Centro psicopedagógico Reina Sofía
Armilla, Spain
3
Unidad de Salud Mental Comunitaria Cabra
Cabra, Spain
4
Residencia Rodríguez Penalva
Castril, Spain