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NCT07609953Completed

Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia

Effectiveness of Cognitive Behavioral Therapy as Adjunctive Therapy on Cognitive Function and Serum Brain-Derived Neurotrophic Factor Levels in Patients With Schizophrenia Receiving Risperidone Therapy

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

This study evaluated whether cognitive behavioral therapy (CBT), when added to risperidone treatment, improves cognitive function and serum brain-derived neurotrophic factor (BDNF) levels in patients with schizophrenia. Participants were adults with stable-phase schizophrenia who were receiving risperidone therapy. They were assigned to either a control group receiving risperidone alone or an intervention group receiving risperidone plus 10 weekly CBT sessions. Cognitive function was assessed using the Indonesian version of the Cognitive Assessment Interview (CAI-Ina). Serum BDNF levels were measured from blood samples using an enzyme-linked immunosorbent assay (ELISA). Measurements were performed at baseline and after 10 weeks. The study was conducted at Rumah Sakit Khusus Daerah Dadi, South Sulawesi, Indonesia.

Status (registry)
Completed
Study type
Interventional
Enrollment
42 (actual)
First submitted
20 May 2026
Start date
1 Nov 2025
Primary completion date
31 Jan 2026
Lead sponsor
Hasanuddin University
NCT number
NCT07609953

What you commit to

  • Study type: Interventional
  • Participants enrolled: 42
  • From 1 Nov 2025 to the primary completion date, 31 Jan 2026
  • 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

  • Use of anti-inflammatory drugs, antibiotics, or antioxidant medications.
  • Unwilling to attend cognitive behavioral therapy sessions.

Other illness

  • History of substance use before hospital admission, except caffeine and nicotine.

Lab values

  • Presence of organic comorbid conditions, such as neurological disorders, severe endocrine or metabolic disorders, chronic liver or kidney disease, or systemic infection, that may affect cognitive function or serum BDNF levels.

Other

  • Intellectual disability or mental retardation.

Who the study is looking for

  • Patients diagnosed with schizophrenia according to DSM-5 and PPDGJ-III criteria.
  • Illness onset of schizophrenia ≤ 5 years since the first appearance of symptoms.
  • Age 20 to 50 years.
  • Clinically stable phase, defined as PANSS score 30 to 60.
  • Receiving risperidone therapy at a dose of 4 to 6 mg/day.
  • Minimum educational level of senior high school.
  • Willing to participate in the study and sign informed consent.

Age in the registry: 20 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan
Coordinator of this site? Confirm its status
MakassarIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.