An assessment of effects of melatonin on metabolic effects of olanzapine in patients with schizophrenia

Phase 3

Conditions: schizophrenia.
Schizophrenia, schizotypal and delusional disorders
F20-f29

Registration Number: IRCT201107187049N1

Lead Sponsor: Guilan University of Medical ScienceS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria: age 18-65 year?diagnosis of schizophrenia based on DSM-IV-TR? capability to take drugs at 9.00 pm
Exclusion criteria: married women who are at reproductive age; history of drug abuse or dependence in the recent 30 days;history of taking olanzapine in the recent 3 months;history of allergy or intolerance to olanzapine; history of significant head trauma ( causing loss of concioussness more than 5 minutes or neurolgical or cognitive sequels);liver, kidney, cerebrovascular or cardiovascular disease;diabetes;metabolic syndrome; cancer ;using antiepileptic , antihypertensive or anticoagulant or anti-platelet drugs; using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvuxamine, ciprofloxacin, carbamazepine, and modafinil) ; patients develop diabetes; acidosis; severe anticholinergic side effects; delirium or need for administration of another drug

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TRIGLYCERIDE. Timepoint: baseline,week 4,8,12. Method of measurement: Enzymatic procedure.;Waist cicumference. Timepoint: baseline,week 4,8,12. Method of measurement: with a plastic meter.;Body mass index. Timepoint: baseline,week 4,8,12. Method of measurement: calculated as body weight(kg)divided by the height in meters square.;Waist to hip ratio. Timepoint: baseline,week 4,8,12. Method of measurement: with a plastic meter.;LDL. Timepoint: baseline,week 4,8,12. Method of measurement: Enzymatic procedure.;HDL. Timepoint: baseline,week 4,8,12. Method of measurement: Enzymatic Procedure.;FBS. Timepoint: baseline,week 4,8,12. Method of measurement: Enzymatic Procedure.;Insulin resistance index. Timepoint: baseline and at the end of intervention. Method of measurement: with HOMA formula.;Fasting serum Insulin values. Timepoint: baseline and at the end of intervention. Method of measurement: ELISA.;Blood pressure. Timepoint: baseline,week 4,8,12. Method of measurement: mercury sphygmomanometer.

Secondary Outcome Measures

Name	Time	Method
Improvement of sleep problems. Timepoint: base,week 4,8,12. Method of measurement: pittsburgh quality of sleep.;Severity of psychosis. Timepoint: baseline,week 4,8,12. Method of measurement: scale measurement by PANSS.