drugset / Trial / NCT07477301

Supportive Psychotherapy as Adjunct to Risperidone for Cognitive Function and Inflammation in Schizophrenia

NCT07477301

Phase 2 Completed 46 enrolled Hasanuddin University
RandomizedParallel-groupDouble-blindTreatment

Summary

This study examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing inflammation in patients with schizophrenia. Forty-six male patients with schizophrenia were randomly assigned to two groups: the intervention group (n=23) received risperidone 4 mg/day plus 12 sessions of structured supportive psychotherapy over 6 weeks. The control group (n=23) received risperidone 4 mg/day alone for 6 weeks. Cognitive function was measured using the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) and inflammation was measured using serum high-sensitivity C-reactive protein (hs-CRP) levels, both assessed at baseline (Week 0) and after treatment (Week 6). NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance (No. 1009/UN4.6.4.5.31/PP36/2024) from the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin, prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.

Timeline

Start
2024-12-01
Primary completion
2025-02-28
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Background Risperidone Other / unclassified 2 mg Oral

Indications