Study to Compare Clozapine vs Treatment as Usual in People With

Status Active, not recruiting

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04529226
Study type	Interventional
Source	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 26, 2020
Completion date	December 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04929938` - Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients	N/A
Recruiting	`NCT05863572` - Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda	N/A
Completed	`NCT04277585` - Improving Access to Early Psychosis Coordinated Specialty Care	N/A
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Recruiting	`NCT05769933` - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Not yet recruiting	`NCT05558332` - Youth Nominated Support Team	N/A
Not yet recruiting	`NCT05358457` - Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)	N/A
Not yet recruiting	`NCT03807388` - ReMindCare App for Patients From First Episode of Psychosis Unit.	N/A
Completed	`NCT02895269` - COllaborative Shared Care to IMprove Psychosis Outcome	N/A
Recruiting	`NCT02622048` - Understanding and Helping Families: Parents With Psychosis	N/A
Completed	`NCT02531243` - Computer-Aided Learning for Managing Stress	N/A
Completed	`NCT02733575` - Compassion Focused Therapy for Distressing Experiences	N/A
Completed	`NCT02653729` - Cbt for Psychosis and Affect on Psychosis Symptoms	Phase 2
Not yet recruiting	`NCT02244970` - Mindfulness RCT for Early Psychosis	N/A
Enrolling by invitation	`NCT01364818` - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment	N/A
Withdrawn	`NCT00786318` - Ziprasidone vs Standard Therapy for Agitated Patients in the ED	Phase 4
Recruiting	`NCT00722163` - A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis	Phase 0

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms