Psychotic Disorders, Schizophrenia
Conditions
Keywords
Curcumin, IL-1β, Quality of Life, WHOQOL-BREF, Risperidone, Inflammation, Adjunct Therapy
Brief summary
This study aims to evaluate the effect of curcumin extract as an adjuvant therapy on quality of life and inflammatory markers in patients with schizophrenia receiving risperidone. Schizophrenia is associated with impaired quality of life and increased inflammatory activity, including elevated levels of interleukin-1 beta (IL-1β). In this randomized clinical trial, patients with schizophrenia are assigned to receive either risperidone alone or risperidone combined with curcumin extract for 8 weeks. Quality of life is assessed using the WHOQOL-BREF questionnaire, and serum IL-1β levels are measured at baseline and after the intervention. The study investigates whether curcumin, known for its anti-inflammatory and antioxidant properties, can improve clinical outcomes and reduce systemic inflammation in patients with schizophrenia.
Detailed description
Schizophrenia is a chronic psychiatric disorder characterized by cognitive impairment, social dysfunction, and reduced quality of life. Emerging evidence suggests that neuroinflammation plays a significant role in the pathophysiology of schizophrenia, with elevated levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β) observed in patients. Curcumin, a bioactive compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and neuroprotective properties. It has been shown to modulate inflammatory pathways, including inhibition of nuclear factor-kappa B (NF-κB), and may reduce cytokine production. These properties suggest that curcumin could serve as a potential adjunctive therapy in schizophrenia. This study is a randomized clinical trial conducted at Rumah Sakit Khusus Daerah (RSKD) Dadi, South Sulawesi, Indonesia. Participants diagnosed with schizophrenia according to ICD-10 criteria and receiving risperidone therapy are randomly assigned into two groups: (1) a control group receiving risperidone alone, and (2) an intervention group receiving risperidone combined with curcumin extract (1000 mg/day) for 8 weeks. Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument at baseline, week 4, and week 8. Serum IL-1β levels are measured at baseline and week 8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to determine the effect of curcumin as an adjuvant therapy on quality of life and IL-1β levels in patients with schizophrenia. Secondary analyses include comparisons of changes between groups and evaluation of the correlation between inflammatory markers and quality of life outcomes. This study is expected to provide evidence on the role of curcumin as a safe and effective adjunctive therapy targeting inflammatory pathways to improve clinical outcomes in schizophrenia.
Interventions
DIETARY_SUPPLEMENTCurcumin
Curcumin extract 1000 mg/day administered orally as an adjuvant therapy in combination with risperidone for 8 weeks.
Risperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks.
Sponsors
Rinvil Renaldi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This study is single-blind, where participants are not aware of their group allocation. Investigators are aware of the assigned interventions to ensure proper clinical monitoring.
Intervention model description
Participants are randomized into two parallel groups: one receiving risperidone plus curcumin extract and the other receiving risperidone alone for 8 weeks.
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Male patients diagnosed with schizophrenia based on ICD-10 criteria * Age between 20 and 45 years * Insight level of 4 * Disease onset less than 12 months * Post-acute phase with PANSS-EC score \< 15 * Receiving risperidone 4 mg/day * Willing to participate and provide informed consent
Exclusion criteria
* Presence of significant medical comorbidities * History of substance abuse within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Interleukin-1 Beta (IL-1β) Levels | Baseline and Week 8 | Serum IL-1β levels are measured using ELISA and expressed in pg/mL. Change from baseline to week 8 is evaluated. |
| Change in Quality of Life (WHOQOL-BREF Score) | Baseline, Week 4, and Week 8 | Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), Indonesian version. The instrument consists of 26 items and evaluates four domains: physical health, psychological well-being, social relationships, and environment. Scores are transformed to a scale of 0-100, where higher scores indicate better quality of life. Changes from baseline to week 4 and week 8 are evaluated. |
Countries
Indonesia
Outcome results
None listed