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THE EFFECT OF MELATONIN ADJUVANT ON COGNITIVE FUNCTION AND MELATONIN LEVELS OF SCHIZOPHRENIA PATIENTS RECEIVING RISPERIDONE THERAPY

THE EFFECT OF MELATONIN ADJUVANT ON COGNITIVE FUNCTION AND MELATONIN LEVELS OF SCHIZOPHRENIA PATIENTS RECEIVING RISPERIDONE THERAPY

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250222001
Enrollment
44
Registered
2025-02-22
Start date
2023-07-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Schizophrenia, Melatonin, Risperidone, Cognitive function

Interventions

22 participants included in treatment group receiving risperidone 4-6 mg/day + adjuvant melatonin 5 mg/day for 8 weeks, patients underwent follow-up with cognitive function assessment using the MoCA-I
Experimental Drug,Placebo Comparator Drug

Sponsors

None listed

Eligibility

Sex/Gender
Male
Age
25 Years to 45 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were : 1. patients diagnosed with schizophrenia according to ICD 10 2. Aged 20-45 years, with the onset of the disease <1 year 3. Had passed the acute phase (PANSS-EC score <15) 4. Had disturbed sleep (Pittsburgh Sleep Quality Index score> 5) 5. Were able and willing to participate in the study, and received risperidone therapy 4-6 mg/day

Exclusion criteria

Exclusion criteria: The exclusion criteria were : 1. Having organic comorbidities 2. Having a history of drug use in the last 6 months before hospitalization 3. Using anti-inflammatory drugs and antibiotics.

Design outcomes

Primary

MeasureTime frame
Cognitive Function Baseline and week 8 Numeric / Total Score of cognitive function using the Montreal Cognitive Assessment- Indonesian Version

Secondary

MeasureTime frame
Melatonin serum level Baseline and week 8 Numeric was evaluated by blood specimens were taken from the median cubital vein, centrifuged, and then examined using an ELISA Kit (Humat MT, Elabsience) according to the protocol

Countries

Indonesia

Contacts

Public ContactChristian Junaedi

Hasanuddin University

christianharyanto122@gmail.com081299258720

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026