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

NCT07477301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Structured Supportive Psychotherapy

Structured supportive psychotherapy using the Supportive Psychotherapy Module for Schizophrenia (Suhuyanli et al.), nationally validated in the Indonesian population. Consisting of 12 structured sessions delivered twice weekly over 6 weeks (15-30 minutes per session), organized into initial (sessions 1-3), middle (sessions 4-9), and termination phases (sessions 10-12). Sessions were delivered by three trained psychiatrists supervised by a consultant in medical psychotherapy. To minimize expectation bias, the intervention was described to all participants as "standard supportive counseling."

DRUG

Risperidone 2 mg

Risperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 6 weeks. Administered to both the intervention group (in combination with supportive psychotherapy) and the control group (as monotherapy).

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Agus Durman, MD · Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

  • Indrawaty Suhuyanli, MD · Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477301 on ClinicalTrials.gov