Patient with schizophrenia. Schizophrenia Melatonin Weight gain
Conditions
Interventions
melatonin 20 mg,
General drug house product,
approved by G.M.P. (Good Manufacturing Practice) intake before bed.,Placebo,
Genneral drug house product.
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Sponsors
Faculty of Medicine, Khonkaen University
Department of Pharmacology
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: patients who had diagnosis schizophrenia as DSM-V criteria with second generation antipsychotic drug used, age between 18-65 years old and understand the information for consent.
Exclusion criteria
Exclusion criteria: Melatonin allergy, Renal impairment (Serum Cr > 1.5 ml/min)or Liver impairment (ALT > 100 U/L or AST> 100 U/L), pregnancy or take oral contraceptive pill, patient who use drug that inhibit CYP caused effect dose of melatonin such as omeprazole rifampicin fluvoxamine ciprofloxacin carbamazepine Modafinil. , dementia and delirium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain At baseline, Week 4, week 8 and week 12 Weight from baseline (kg) | — |
Secondary
| Measure | Time frame |
|---|---|
| oxidative stress in urine At baseline and week 12 Urine 8-isoprostane,Severity of psychotic symptom At baseline, Week 4, week 8 and week 12 Brief psychiatric rating scale | — |
Countries
Thailand
Contacts
Public ContactPongsatorn Paholpak
Lecturer
Outcome results
None listed