Clinical Trial

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

Study acronym: SUPPORT-SCZ
Completed Phase 2
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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.
Trial Details
NCT Number NCT07477301
Lead Sponsor Hasanuddin University
Conditions Schizophrenia, Cognitive Dysfunction, Inflamation
Enrollment 46 participants
Start Date 2024-12-01
Primary Completion 2025-02-28 (estimated)
Study Completion 2025-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-03-17