Treatment-resistant schizophrenia and schizoafective disorder
Conditions
Interventions
Trade Name: Clozapine
Product Name: Clozapine
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOZAPINE
CAS Number: 0005786-21-0
Other descriptive name: CLOZAPINE
Concentration unit: mg milligram(s)
Sponsors
Fundación Hospital Provincial de Castellón
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-To assess tolerability, the UKU scale score will be assessed. 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. | — |
Countries
Spain
Contacts
Public ContactFundación Hospital Provincial de Ca
Fundación Hospital Provincial de Castellón
Outcome results
None listed