ARIPIPRAZOLE for Schizophrenia | First episode psychosis | Treatment-resistant schizophrenia

Inclusion criteria

• {"criterion_text":"- Patients aged between 15 and 40 years.\n- Patients who live in the area of influence of the site.\n- Patients who are experiencing their first psychotic episode.\n- Patients with diagnoses of the schizophrenia spectrum according to DSM-5 (schizophreniform disorder, schizophrenia, schizoaffective disorder, brief psychotic disorder or psychotic disorder not otherwise specified)."}

Exclusion criteria

• {"criterion_text":"- Be on antipsychotic treatment for >6 weeks at the time of study drug randomization.\n- Patients who meet the DSM-5 criteria for substance dependence (other than tobacco or cannabis).\n- Patients who meet the DSM-5 criteria for intelectual disability.\n- Patients with a history of neurological pathology or traumatic brain injury.\n- Being pregnant.\n- Chronic treatment (>3 months) with oral or intramuscular corticosteroids or immunosuppressive treatment."}

Primary endpoints

• {"endpoint_text":"- Therapeutic response to aripiprazole or paliperidone","definition_or_measurement_approach":"Assessed as therapeutic response after 3 months; efficacy assessed by defining \"responder\" using PANSS and CGI-S scales (as described in trial objectives)."}

Secondary endpoints

• {"endpoint_text":"- Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline.","definition_or_measurement_approach":"Change in PANSS positive symptom subscale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline.","definition_or_measurement_approach":"Change in PANSS negative symptom subscale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Change in negative symptoms assessed with the SANS at 3 and 12 months. Measured as a change in the SANS scale score compared to baseline.","definition_or_measurement_approach":"Change in SANS scale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline.","definition_or_measurement_approach":"Change in CDS (CDSS) scale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline.","definition_or_measurement_approach":"Change in PSP scale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Change in quality of life at 3 and 12 months. Measured as a change in the visual-analog scale of the EuroQoL scale with respect to baseline.","definition_or_measurement_approach":"Change in EuroQoL visual-analog scale score from baseline at 3 and 12 months."}
• {"endpoint_text":"- Side effects at 3 and 12 months evaluated with the UKU scale. The total score (number of side effects) and qualitatively each side effect are assessed.","definition_or_measurement_approach":"Total UKU score (number of side effects) and qualitative assessment of each side effect at 3 and 12 months."}
• {"endpoint_text":"- Changes at 3 and 12 months in anthropometric measurements (weight, BMI, abdominal circumference), cardiovascular (blood pressure, heart rate) and laboratory tests (glycaemia, lipid profile, prolactin).","definition_or_measurement_approach":"Measured changes in weight, BMI, abdominal circumference, blood pressure, heart rate, and laboratory values (glycaemia, lipid profile, prolactin) at 3 and 12 months compared to baseline."}

Spain

Earliest CTIS Part Ii Submission Date

03-12-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

13

Number Of Sites

12

Number Of Participants

244

Primary sponsor

Full Name

Consorcio Centro De Investigacion Biomedica En Red

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain