This study is a double blind controlled clinical trial to evaluate the effect of melatonin in reducing metabolic effects of second-generation antipsychotic drugs on patients 18 to 64 years old who has just been nominated for a second-generation antipsychotic medications. Patients with high blood pressure, diabetes, lipid disorders, thyroid disorders, and liver disease and patients who at any time during the study antipsychotic drugs abandoned or Do not take two doses of melatonin pill, are excluded.
The study included 100 patients in each group of 50 people, and in the absence of exit criteria are enrolled for 8 weeks. a group of patients were administrated melatonin at a dose of 3 mg and placebo given to the control group, and the first and fourth week and eighth week of the study, changes in blood lipid profiles, blood sugar and blood pressure, waist circumference and body mass index are considered .
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Effect of Melatonin in side effects of second-generation antipsychotic medications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
men and women 18 to 64 years old who have recently been treated with second-generation antipsychotics; Exclusion criteria: patients with high blood pressure, diabetes, lipid disorders, thyroid disorders and liver diseases; a history of sensitivity to melatonin; high risk of suicide or aggression; pregnant women or lactating; patients at any time during the study drugs antipsychotic abandoned or Do not take two doses of melatonin pill; substance Abuse or dependence in the last 6 months;
Age
From 18 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University Of Medical Sciences
Street address
5th Km, Ravand Blv, Kashan
City
Kashan
Postal code
Approval date
2015-01-28, 1393/11/08
Ethics committee reference number
93184
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
2
Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
blood pressure
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
mmhg
2
Description
HDL
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
mg/dl
3
Description
FBS
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
mg/dl
4
Description
cholesterol
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
mg/dl
5
Description
BMI
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
kg/m2
6
Description
waist
Timepoint
before intervention and the end of 4th week & 8th week
Method of measurement
cm
Secondary outcomes
1
Description
side effects of melatonin
Timepoint
the end of 4th week & 8th week
Method of measurement
clinical interview and physical examination
Intervention groups
1
Description
control: Tab Placebo Hs oral for 8 weeks
Category
Prevention
2
Description
intervention: melatonin tablet 3 mg oral HS for 8 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Karegarnejad Hospital
Full name of responsible person
Mansour Agahi
Street address
5th km, Ravand Blv, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi MD
Street address
5th Km, Ravand Blv, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?