Psychosis Clinical Trial
— CLOZ-AIDOfficial title:
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.
Verified date | March 2024 |
Source | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | December 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Unidad de Salud Mental Comunitaria Andújar | Andújar | |
Spain | Centro psicopedagógico Reina Sofía | Armilla | |
Spain | Unidad de Salud Mental Comunitaria Cabra | Cabra | |
Spain | Residencia Rodríguez Penalva | Castril | |
Spain | Hospital Universitario Reina Sofía | Córdoba | |
Spain | Unidad de Salud Mental Comunitaria Córdoba Sur | Córdoba | |
Spain | Fundación Purísima Concepción Hermanas Hospitalarias | Granada | |
Spain | Hospital Universitario Clínico San Cecilio | Granada | |
Spain | Hospital Universitario de Jerez | Jerez De La Frontera | |
Spain | Residencia de Adultos María Dacia González Gordón | Jerez De La Frontera | |
Spain | Residencia para personas con Discapacidad intelectual Gravemente Afectadas Vista Hermosa | Jerez De La Frontera | |
Spain | Centro Asistencial San Juan de Dios | Málaga | |
Spain | Hospital Regional Universitario | Málaga | |
Spain | Unidad de Salud Mental Comunitaria Montilla | Montilla | |
Spain | Unidad de Salud Mental Comunitaria Montoro | Montoro | |
Spain | Villablanca Serveis Assistencials | Reus | |
Spain | Residencia de gravemente afectados Virgen de la Caridad | Sanlúcar De Barrameda | |
Spain | Hospital Universitario Virgen del Rocío | Seville | |
Spain | Hospital Universitario Virgen Macarena | Seville | |
Spain | Centro Ocupacional El Curtido | Ubrique |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Clinical improvement based on Positive and Negative Syndrome Scale (PANSS) | Clinical improvement as measured by change from baseline to last study visit score Subjects rated from 1 to 7 on 30 different symptoms (items). Positive scale 7 Items. minimum score = 7, maximum score = 49 Negative scale 7 Items. minimum score = 7, maximum score = 49 General Psychopathology scale 16 Items. minimum score = 16, maximum score = 112 PANSS Total score minimum = 30, maximum = 210 |
Baseline and 12 Months | |
Secondary | Clinical improvement based on Scale for the Assessment of Negative Symptoms (SANS) | Clinical improvement as measured by change from baseline to last study visit score. SANS is split into 5 domains, and within each domain separate symptoms are rated through a 6-point scale from 0 (absent) to 5 (severe). SANS Total score minimum = 0, maximum = 125 |
Baseline and 12 Months | |
Secondary | Quality of Life Improvement based on the 5 levels Quality of Life 5 dimensional (5D) 5 levels (5L) questionnaire (Euro-QoL 5D-5L scale) | Generic health status improvement measured by change from baseline to last study visit scores | Baseline and 12 Months | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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 |
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