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PsychosisPhase 2CLOZ-AIDNCT04529226

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

A Phase 2 study testing Clozapine and haloperidol, pimozide, olanzapine, risperidone, amisulpride in people with Psychosis and Intellectual Disability, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 20 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 55 years
Conditions the study is for
Psychosis, Intellectual Disability
What is being tested?
Clozapine and haloperidol, pimozide, olanzapine, risperidone, amisulpride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
20 sitesSpain
Study dates
26 Nov 2020to 30 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Unidad de Salud Mental Comunitaria Andújar

    Andújar

  • Centro psicopedagógico Reina Sofía

    Armilla

  • Unidad de Salud Mental Comunitaria Cabra

    Cabra

  • Residencia Rodríguez Penalva

    Castril

  • Hospital Universitario Reina Sofía

    Córdoba

  • Unidad de Salud Mental Comunitaria Córdoba Sur

    Córdoba

  • Fundación Purísima Concepción Hermanas Hospitalarias

    Granada

  • Hospital Universitario Clínico San Cecilio

    Granada

  • Hospital Universitario de Jerez

    Jerez de la Frontera

  • Residencia de Adultos María Dacia González Gordón

    Jerez de la Frontera

  • Residencia para personas con Discapacidad intelectual Gravemente Afectadas Vista Hermosa

    Jerez de la Frontera

  • Centro Asistencial San Juan de Dios

    Málaga

  • Hospital Regional Universitario

    Málaga

  • Unidad de Salud Mental Comunitaria Montilla

    Montilla

  • Unidad de Salud Mental Comunitaria Montoro

    Montoro

  • Villablanca Serveis Assistencials

    Reus

  • Residencia de gravemente afectados Virgen de la Caridad

    Sanlúcar de Barrameda

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Centro Ocupacional El Curtido

    Ubrique

Other trials in Spain

About this study

Official 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.

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.

Read the 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 with intellectual disability and treatment-resistant psychosis.

Clozapine is the most effective antipsychotic for patients with non-affective psychosis who do not respond to other first and second generation antipsychotic treatments. In addition, it has been shown to be very effective in another series of clinical situations such as hostility and aggressiveness, polydipsia and in behavioral disorders and psychosis, frequent situations in people with intellectual disabilities.

The primary objective is to assess the efficacy and safety of clozapine versus standard clinical practice treatment in patients with intellectual disability and resistant psychotic disorder, as measured by change in Clinical Global Impression: Clinical Global Impression-Schizophrenia scale (ICG-SCH) global score over trial visits.

The study determines to reach a sample size of 114 patients distributed among the 25 active centers. Randomization is 1:1 and consists of 6 visits to the center spread over 12 months. At each visit, the patient will undergo a physical examination and sample collection, along with a clinical and cognitive evaluation using the scales provided in accordance with the clinical guidelines.

In addition, if the patient falls into the experimental arm (Clozapine), it is necessary to collect a blood sample weekly during the first 18 weeks and biweekly until completing the 12 months of the study, so that the medical team has special control in the analytical parameters.

Being tested
Clozapine, haloperidol, pimozide, olanzapine, risperidone, amisulpride
Medical subject headings
Psychotic Disorders, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClozapineDrug

    Also called Nemex, Leponex

    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

  • haloperidol, pimozide, olanzapine, risperidone, amisulprideDrug

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

Study groups in NCT04529226
Study groupRoleWhat they receive
ClozapineExperimentalPharmaceutical Form: Tablet Anatomical Therapeutic Chemical classification system (ATC Code): N: nervous system, N05: psycholeptic, N05A: antipsychotic, N05AH02: clozapine (N05AH02)
Receives: Drug: Clozapine
ControlActive comparatorUsual antipsychotic medication used in the treatment of treatment-resistant psychosis.
Receives: Drug: haloperidol, pimozide, olanzapine, risperidone, amisulpride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 12 Months

Secondary outcomes (4)

  1. 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

    Measured: Baseline and 12 Months

  2. 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

    Measured: Baseline and 12 Months

  3. 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

    Measured: Baseline and 12 Months

  4. 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

    Measured: Up to 28 days after the last investigational medicinal product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start26 Nov 2020
  3. Primary completion30 Jan 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529226
Sponsor's protocol ID
CLOZ-AID
Other IDs
2020-000091-37
Acronym
CLOZ-AID
Status last verified
Mar 2024
First submitted
25 Aug 2020
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38807685

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clozapine and haloperidol, pimozide, olanzapine, risperidone, amisulpride in people with Psychosis and Intellectual Disability, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score. (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529226, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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