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

NCT07477301 | Completed Phase 2

• 1 other identifier: AGUS-SP-RIS-SCZ-2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Cognitive Dysfunction; Inflamation

Keywords

Schizophrenia; Supportive Psychotherapy; Risperidone; Cognitive Function; C-Reactive Protein; Randomized Controlled Trial; Inflammation

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function (MoCA-Ina Score)

  Change in cognitive function assessed by the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6. Score range 0-30; higher scores indicate better cognitive function. Inter-rater reliability kappa=0.820.

  Baseline (Week 0) and post-intervention (Week 6)

• Change in Serum hs-CRP Level

  Change in serum high-sensitivity C-reactive protein (hs-CRP) level from baseline to Week 6, measured by Sandwich-ELISA (Elabscience Human hs-CRP ELISA Kit, Cat. No. E-EL-H5134; detection range 15.63-1000 pg/mL; sensitivity 9.38 pg/mL).

  Baseline (Week 0) and post-intervention (Week 6)

Secondary Outcomes (1)

• Correlation Between Delta hs-CRP and Delta MoCA-Ina

  Week 6 (end of intervention)

Study Arms (2)

Supportive Psychotherapy plus Risperidone

EXPERIMENTAL

Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). Supportive psychotherapy was delivered using a validated module by the principal investigator.

Behavioral: Structured Supportive Psychotherapy; Drug: Risperidone 2 mg

Risperidone Monotherapy

ACTIVE COMPARATOR

Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) monotherapy for 6 weeks without any structured psychotherapy intervention.

Drug: Risperidone 2 mg

Interventions

Structured Supportive Psychotherapy BEHAVIORAL

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."

Supportive Psychotherapy plus Risperidone

Risperidone 2 mg DRUG

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).

Risperidone Monotherapy; Supportive Psychotherapy plus Risperidone

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients diagnosed with schizophrenia according to DSM-5 criteria
• Aged 20-45 years
• Disease onset less than one year
• Insight level grade 4
• PANSS-EC score 14 or less
• Total PANSS score 60-70
• No febrile conditions, jaundice, or hepatosplenomegaly
• Willing and able to attend supportive psychotherapy sessions
• Receiving risperidone at fixed dose of 4 mg per day
• South Sulawesi ethnic origin

You may not qualify if:

• Organic comorbid diseases
• History of substance abuse within previous six months except caffeine and nicotine
• Comorbid personality disorders
• Obesity
• Active infectious diseases
• Use of anti-inflammatory agents, antibiotics, or antioxidant supplements
• Female sex

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dadi Psychiatric Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction; Inflammation

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Agus Durman, MD

  Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

  PRINCIPAL INVESTIGATOR

• Indrawaty Suhuyanli, MD

  Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant blinding was achieved by describing the intervention to all participants as "standard supportive counseling," thereby preventing identification of group allocation and minimizing expectation bias. The structured supportive psychotherapy module used in the intervention group was not disclosed to participants. Outcomes assessors who evaluated MoCA-Ina scores and laboratory personnel who measured serum hs-CRP levels were fully blinded to participants' allocation status throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This parallel-group RCT compared two arms over 6 weeks. Participants were randomly allocated in a 1:1 ratio using a simple random number generator by an independent researcher not involved in clinical recruitment.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 17, 2026
• Study Start: December 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

ID (1)