Comparative analysis of the effectiveness of clozapine in resistant schizophrenia and schizoafective disorder.

Phase 1

• Conditions: Treatment-resistant schizophrenia and schizoafective disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-001278-44-ES
• Lead Sponsor: Fundación Hospital Provincial de Castellón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Patients diagnosed with treatment-resistant schizophrenia or schizoafective disorder, regardless of consumption (or not) psychoactive substances.
2.Patients who at the time of recruitment maintain values in the PANSS equal to or greater than 80, despite the prescribed pharmacological regimen.
3.Patients who accept, by signing informed consent, voluntarily participate in the study. In patients with capacity modification, the consent of the guardian will be required.
4.Patients who have clozapine prescribed below the minimum therapeutic dose prescribed for the trial (150 mg daily)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1.Patients with other psychiatric diagnoses, different from those reflected in the inclusion criteria.
2. Patients with treatment-resistant schizophrenia or schizoaffective disorder who score below 80 in PANSS at the time of recruitment or have more than 150 mg of clozapine prescribed daily.
3. Pacientes que presenten contraindicaciones absolutas para la prescripción de clozapina: prescripción de tratamiento mielosupresor, antecedentes de agranulocitosis, enfermedades mieloproliferativas, epilepsia no controlada, depresión del SNC o íleo paralítico.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effectiveness of clozapine, in association with other antipsychotics, in reducing psychotic symptomatology in treatment-resistant schizophrenia and schizoafective disorder.;Secondary Objective: 1-Study the tolerability of clozapine in treatment-resistant schizophrenia and schizoafective disorder., identifying differences and similarities.<br>2-Determine the existence of clinical and/or sociodemographic characteristics that help predict the response to clozapine;Primary end point(s): Assess changes (relationship to reducing psychotic symptomatology), and magnitude, in the PANSS scale score in patients with Treatment-resistant schizophrenia and schizoafective disorder. A 25% reduction in the PANSS will be considered to be significant improvement.;Timepoint(s) of evaluation of this end point: The follow-up time to evaluate the changes will be 3 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1-To assess tolerability, the UKU scale score will be assessed.<br>2-Compare the response to Clozapine in the different groups and study correlations of it with the variables included in the sociodemographic, clinical and therapeutic profile.;Timepoint(s) of evaluation of this end point: The follow-up time to evaluate the changes will be 3 months.