Trial | NCT04529226  Report issue

Title

Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
A Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of Clozapine vs Treatment as Usual for Treatment-resistant Psychosis in Adolescents and Young Adults With Intellectual Disability.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    114
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.
Study Started
Nov 26
2020
Primary Completion
Oct 31
2023
Anticipated
Study Completion
Feb 29
2024
Anticipated
Last Update
Jan 12
2021

Drug Clozapine

Start treatment with 12.5 mg every 12 hours with the recommendation to increase dosage by 25-50 mg/day provided it is well tolerated up to a level of 300-450 mg/day at the end of the second week

  • Other names: Nemea, Leponex

Drug haloperidol, pimozide, olanzapine, risperidone, amisulpride [haloperidol (haldol), pimozide (orap), olanzapine (zyprexa), risperidone (risperdal), amisulpride (BARHEMSYS)]

Treatment as usual using first-generation or second-generation antipsychotics

Clozapine Experimental

Pharmaceutical Form: Tablet ATC Code: N05AH02

Control Active Comparator

Usual antipsychotic medication used in the treatment of treatment-resistant psychosis.

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
No Results Posted