Methamphetamine-induced psychosis. Neuro-inflammation. Oxidative stress. Metabolites. Methamphetamine Methamphetamine induced psychosis Melatonin Cytokines Oxidative stress Metabolites Psychosis Insomnia Cognitive function.
Conditions
Interventions
Participants who are allocated into this arm will receive melatonin 10mg per day together with treatment as usual (risperidone, vitamin B, vitamin C).
Duration of treatment: 4 weeks (28 days).,Partici
Experimental Drug,Placebo Comparator Drug
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cytokine network Baseline and after 4 weeks. Bio-Plex Pro Human Cytokine 48-Plex Screening Panel.,Oxidative stress and metabolites Baseline and after 4 weeks Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometry (LC-QTOF-MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Modified Athens Insomnia Severity,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 | — |
Countries
Thailand
Contacts
Public ContactAnh Ngoc Tran
Chulalongkorn University
Outcome results
None listed