Efficacy of melatonin reducing weight gain in patients with schizophrenia using second generation antipsychotic drugs

Phase 4

Recruiting

• Conditions: Patient with schizophrenia.; Schizophrenia; Melatonin; Weight gain

• Registration Number: TCTR20160907002
• Lead Sponsor: Faculty of Medicine, Khonkaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-07
• Study Completion: 2017-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight gain At baseline, Week 4, week 8 and week 12 Weight from baseline (kg)

Secondary Outcome Measures

Name	Time	Method
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