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

Primary Purpose

Psychosis, Intellectual Disability

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Clozapine
haloperidol, pimozide, olanzapine, risperidone, amisulpride
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unidad de Salud Mental Comunitaria Andújar
  • Centro psicopedagógico Reina Sofía
  • Unidad de Salud Mental Comunitaria Cabra
  • Residencia Rodríguez Penalva
  • Hospital Universitario Reina Sofía
  • Unidad de Salud Mental Comunitaria Córdoba Sur
  • Fundación Purísima Concepción Hermanas Hospitalarias
  • Hospital Universitario Clínico San Cecilio
  • Hospital Universitario de Jerez
  • Residencia de Adultos María Dacia González Gordón
  • Residencia para personas con Discapacidad intelectual Gravemente Afectadas Vista Hermosa
  • Unidad de Salud Mental Comunitaria Montilla
  • Unidad de Salud Mental Comunitaria Montoro
  • Centro Asistencial San Juan de Dios
  • Hospital Regional Universitario
  • Villablanca Serveis Assistencials
  • Residencia de gravemente afectados Virgen de la Caridad
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del RocíoRecruiting
  • Centro Ocupacional El Curtido

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clozapine

Control

Arm Description

Pharmaceutical Form: Tablet ATC Code: N05AH02

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Quality of Life Improvement based on the 5-level Quality of Life 5-dimensional questionnaire (Euro-QoL 5D-5L scale)
Generic health status improvement measured by change from baseline to last study visit scores
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

Full Information

First Posted
August 25, 2020
Last Updated
January 11, 2021
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04529226
Brief Title
Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
Acronym
CLOZ-AID
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Intellectual Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clozapine
Arm Type
Experimental
Arm Description
Pharmaceutical Form: Tablet ATC Code: N05AH02
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual antipsychotic medication used in the treatment of treatment-resistant psychosis.
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Nemea, Leponex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
haloperidol, pimozide, olanzapine, risperidone, amisulpride
Intervention Description
Treatment as usual using first-generation or second-generation antipsychotics
Primary Outcome Measure Information:
Title
Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score.
Description
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
Time Frame
Baseline and 12 Months
Secondary Outcome Measure Information:
Title
Clinical improvement based on Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
Baseline and 12 Months
Title
Clinical improvement based on Scale for the Assessment of Negative Symptoms (SANS)
Description
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
Time Frame
Baseline and 12 Months
Title
Quality of Life Improvement based on the 5-level Quality of Life 5-dimensional questionnaire (Euro-QoL 5D-5L scale)
Description
Generic health status improvement measured by change from baseline to last study visit scores
Time Frame
Baseline and 12 Months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Up to 28 days after the last investigational medicinal product administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Rosso Fernández, PhD
Phone
+34 955 013414
Email
claram.rosso.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo Facorro, Professor
Organizational Affiliation
Andalusian Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Salud Mental Comunitaria Andújar
City
Andújar
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Gómez Moreno
Email
cristinagomezmoreno@hotmail.com
Facility Name
Centro psicopedagógico Reina Sofía
City
Armilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge C Cervilla Ballesteros
Email
jcervilla@ugr.es
Facility Name
Unidad de Salud Mental Comunitaria Cabra
City
Cabra
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Carrion Exposito
Email
laura-ce85@hotmail.com
Facility Name
Residencia Rodríguez Penalva
City
Castril
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cervilla Ballesteros
Email
jcervilla@ugr.es
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Sarramea Crespo
Email
fscferro69@gmail.com
Facility Name
Unidad de Salud Mental Comunitaria Córdoba Sur
City
Córdoba
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Sarramea Crespo
Email
fscferro69@gmail.com
Facility Name
Fundación Purísima Concepción Hermanas Hospitalarias
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Ballesteros
Email
jcervilla@ugr.es
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cervilla Ballesteros
Email
jcervilla@ugr.es
Facility Name
Hospital Universitario de Jerez
City
Jerez De La Frontera
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Villagran Romero
Email
jmaria.villagran.sspa@juntadeandalucia.es
Facility Name
Residencia de Adultos María Dacia González Gordón
City
Jerez De La Frontera
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Villagrán Romero
Email
jmaria.villagran.sspa@juntadeandalucia.es
Facility Name
Residencia para personas con Discapacidad intelectual Gravemente Afectadas Vista Hermosa
City
Jerez De La Frontera
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Villagran Romero
Email
jmaria.villagran.sspa@juntadeandalucia.es
Facility Name
Unidad de Salud Mental Comunitaria Montilla
City
Montilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Sarramea Crespo
Email
fscferro69@gmail.com
Facility Name
Unidad de Salud Mental Comunitaria Montoro
City
Montoro
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando C Sarramea Crespo
Email
fscferro69@gmail.com
Facility Name
Centro Asistencial San Juan de Dios
City
Málaga
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melquiades Leon Macias
Email
fermin.mayoral.sspa@juntadeandalucia.es
Facility Name
Hospital Regional Universitario
City
Málaga
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fermín Mayoral Cleries
Email
fermin.mayoral.sspa@juntadeandalucia.es
Facility Name
Villablanca Serveis Assistencials
City
Reus
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Martínez Leal
Email
rmarleal@gmail.com
Facility Name
Residencia de gravemente afectados Virgen de la Caridad
City
Sanlúcar De Barrameda
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Villagrán Romero
Email
jmaria.villagran.sspa@juntadeandalucia.es
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Romero Guillena
Email
samuel.forqueta@gmail.com
Facility Name
Hospital Universitario Virgen del Rocío
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo-Facorro, Professor
Phone
+34671596675
Email
benedicto.crespo.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Idalino Rocha, MSc
Phone
+34689366067
Email
idalino.rocha@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo-Facorro, Professor
First Name & Middle Initial & Last Name & Degree
Miguel Ruiz-Veguilla, PhD
Facility Name
Centro Ocupacional El Curtido
City
Ubrique
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocío Torrecilla Olavarrieta
Email
rociotorrecillaol@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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