NCT07477301CompletedPhase 2
Supportive Psychotherapy as Adjunct to Risperidone for Cognitive Function and Inflammation in Schizophrenia
Supportive Psychotherapy As An Adjunct To Risperidone Improves Cognitive Function And Reduces High-Sensitivity C-Reactive Protein (Hs-CRP) In Schizophrenia: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 11 Mar 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Hasanuddin University
- Diseases
- Schizophrenia
- NCT number
- NCT07477301
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 46
- From 1 Dec 2024 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of substance abuse within previous six months except caffeine and nicotine
Other illness
- Organic comorbid diseases
- Comorbid personality disorders
- Active infectious diseases
Other
- Obesity
- Use of anti-inflammatory agents, antibiotics, or antioxidant supplements
- Female sex
Who the study is looking for
- 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
Age in the registry: 20 years to 45 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dadi Psychiatric Hospital Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.