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

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20160907002
• Date of registration: 07/09/2016
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine, Khonkaen University
• Public title: Efficacy of melatonin reducing weight gain in patients with schizophrenia using second generation antipsychotic drugs
• Scientific title: Efficacy of melatonin reducing weight gain in patients with schizophrenia using second generation antipsychotic drugs
• Date of first enrolment: 06/08/2016
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160907002
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Pongsatorn Paholpak
• Affiliation: Lecturer

• Name: Pongsatorn Paholpak
• Affiliation: Lecturer

Key inclusion & exclusion 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: 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.

Age minimum: 15 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Patient with schizophrenia.
Schizophrenia
Melatonin
Weight gain

Schizophrenia
Melatonin
Weight gain

Intervention(s)

melatonin 20 mg, General drug house product, approved by G.M.P. (Good Manufacturing Practice) intake before bed.,Placebo, Genneral drug house product.

melatonin,Placebo

Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

Primary Outcome(s)

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

Secondary Outcome(s)

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

Source(s) of Monetary Support

Faculty of Medicine, Khonkaen University

Secondary Sponsor(s)

Department of Pharmacology

Ethics review

Status: Submitted, approved
Approval date:
Contact:

EC KKU

664-336-7133 Ext. 664-336-7134

Results

• Date Completed: 01/08/2017