Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: Amisulpride; Clozapine; Haloperidol; Haloperidol decanoate; Olanzapine; Pimozide; Risperidone

Criteria

Inclusion Criteria:

• Subjects aged between 16 and 40 years

• Diagnosis of intellectual disability according to the Diagnostic and Statistical Manual of Mental Disorders DSM-5 (confirmed by a IQ Score between 35 and 70 in the Kaufman test)

• Diagnosis of psychosis according to the 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