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

NCT04529226 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: CLOZ-AID2020-000091-37
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 20

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 significant improvement in subjects' clinical response and quality of life.

Conditions

Psychosis; Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score.

  Overall Severity of Illness as measured by change from baseline to last study visit score Minimum value = 1 Normal, not ill Maximum value = 7 Among the most severely ill

  Baseline and 12 Months

Secondary Outcomes (4)

• Clinical improvement based on Positive and Negative Syndrome Scale (PANSS)

  Baseline and 12 Months

• Clinical improvement based on Scale for the Assessment of Negative Symptoms (SANS)

  Baseline and 12 Months

• Quality of Life Improvement based on the 5 levels Quality of Life 5 dimensional (5D) 5 levels (5L) questionnaire (Euro-QoL 5D-5L scale)

  Baseline and 12 Months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 28 days after the last investigational medicinal product administration

Study Arms (2)

Clozapine

EXPERIMENTAL

Pharmaceutical Form: Tablet Anatomical Therapeutic Chemical classification system (ATC Code): N: nervous system, N05: psycholeptic, N05A: antipsychotic, N05AH02: clozapine (N05AH02)

Drug: Clozapine

Control

ACTIVE COMPARATOR

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

Drug: haloperidol, pimozide, olanzapine, risperidone, amisulpride

Interventions

Clozapine DRUG

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

Also known as: Nemex, Leponex

Clozapine

haloperidol, pimozide, olanzapine, risperidone, amisulpride DRUG

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

Control

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (20)

Unidad de Salud Mental Comunitaria Andújar

Andújar, Spain

Location

Centro psicopedagógico Reina Sofía

Armilla, Spain

Location

Unidad de Salud Mental Comunitaria Cabra

Cabra, Spain

Location

Residencia Rodríguez Penalva

Castril, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Unidad de Salud Mental Comunitaria Córdoba Sur

Córdoba, Spain

Location

Fundación Purísima Concepción Hermanas Hospitalarias

Granada, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, Spain

Location

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Location

Residencia de Adultos María Dacia González Gordón

Jerez de la Frontera, Spain

Location

Residencia para personas con Discapacidad intelectual Gravemente Afectadas Vista Hermosa

Jerez de la Frontera, Spain

Location

Centro Asistencial San Juan de Dios

Málaga, Spain

Location

Hospital Regional Universitario

Málaga, Spain

Location

Unidad de Salud Mental Comunitaria Montilla

Montilla, Spain

Location

Unidad de Salud Mental Comunitaria Montoro

Montoro, Spain

Location

Villablanca Serveis Assistencials

Reus, Spain

Location

Residencia de gravemente afectados Virgen de la Caridad

Sanlúcar de Barrameda, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Centro Ocupacional El Curtido

Ubrique, Spain

Location

Related Publications (1)

• Alemany-Navarro M, Sanchez-Barbero B, Reguera-Pozuelo P, Altea-Manzano L, Gomez-Garrido A, Rocha-Gonzalez I, Garrido-Torres N, Ruiz-Veguilla M, Garcia-Cerro S, Rosso-Fernandez CM, Villagran-Moreno JM, Sarramea F, Cervilla-Ballesteros J, Martinez-Leal R, Mayoral-Cleries F; CLOZ-AID Group; Crespo-Facorro B. Efficacy of clozapine versus standard treatment in adult individuals with intellectual disability and treatment-resistant psychosis (CLOZAID): study protocol of a multicenter randomized clinical trial. Front Psychiatry. 2024 May 14;15:1400621. doi: 10.3389/fpsyt.2024.1400621. eCollection 2024.

  PMID: 38807685 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Intellectual Disability

Interventions

Clozapine; Pyrantel; Haloperidol; Pimozide; Olanzapine; Risperidone; Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butyrophenones; Ketones; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Benzodiazepines; Benzazepines; Pyrimidinones; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Benedicto Crespo Facorro, Professor

  Andalusian Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 27, 2020
• Study Start: November 26, 2020
• Primary Completion: January 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

ES (20)