Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis

Conditions

Patients with a first psychotic episode, Schizophrenia, Treatment-resistant Schizophrenia

Brief summary

Therapeutic response to aripiprazole or paliperidone

Detailed description

Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline., Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline., 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., Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline., Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline., 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., 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., 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).

Related papers

No related papers found yet.

Interventions

DRUGXeplion 150 mg and Xeplion 100 mg prolonged release suspension for injection

DRUGAbilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe

DRUGBYANNLI 700 mg prolonged-release suspension for injection in pre-filled syringe

DRUGBYANNLI 1 000 mg prolonged-release suspension for injection in pre-filled syringe

DRUGTREVICTA 175 mg prolonged release suspension for injection

DRUGAbilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection

DRUGOKEDI 100 mg powder and solvent for prolonged-release suspension for injection

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Therapeutic response to aripiprazole or paliperidone	—

Secondary

Measure	Time frame
Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline., Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline., 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., Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline., Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline., 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., 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., Changes at 3 and 12 months in anthropometric measurements (weight, BM	—

Measure

Time frame

Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline., Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline., 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., Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline., Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline., 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., 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., Changes at 3 and 12 months in anthropometric measurements (weight, BM

—

Countries

Spain

Outcome results

None listed