Efficacy of melatonin to normalize the cytokines network and balance the oxidative stress in methamphetamine-induced psychosis patients: a double-blinded randomized controlled trial.

Phase 3

• Conditions: Methamphetamine-induced psychosis.Neuro-inflammation.Oxidative stress.; Methamphetamine; Methamphetamine induced psychosis; Melatonin; Cytokines; Oxidative stress,; Psychosis; Insomnia; Cognitive function.

• Registration Number: TCTR20240529005
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Last Update Posted: 19 August 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Participants are newly admitted to PMNIDAT and diagnosed with methamphetamine-induced psychosis.
2. Participants can have history of ultilization of alcohol and nicotine but methamphetamine must be the primary cause of psychosis.
3. Agree to take part in the study.

Exclusion Criteria

1. History of primary psychiatric disorders such as primary psychosis disorders, mood disorders, anxiety disorders, mild and major neurocognitive disorders.
2. History of autoimmune disorders and allergy to melatonin.
3. Currently have any allergic, infectious/inflammatory diseases, or have any signs or symptoms suggesting an allergic/infectious/inflammatory condition.
4. Currently receive any other treatments than the study experimental treatment.
5. Used other substance than methamphetamine, alcohol and nicotine in the last 1 month.
6. Female participants who currently get pregnant or practice breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
euroinflammation Baseline and after 4 weeks. Serum levels of immune biomarkers.,Oxidative stress Baseline and after 4 weeks Serum levels of oxidative stress biomarkers and oxidative stress indexes

Secondary Outcome Measures

Name	Time	Method
Psychotic symptoms Baseline, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28 Positive and Negative Syndrome Scale ,Psychosis symptoms Baseline, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28 Paranoia Worries Questionnaire,Cognitive function Baseline and after 4 weeks. Cambridge Neuropsychological Test Automated Battery,Insomnia Baseline, after 2 weeks and after 4 weeks. Insomnia Severity Index,Time to remission from MAP Baseline, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28 Positive and Negative Syndrome Scale,Time to adverse effects of antipsychotic medication Everyday Modified Simson Angus Scale