Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate: a randomized,double blind, placebo-controlled clinical trial
The objective of this study is to assess the efficacy of melatonin in preventing the development of the components of metabolic syndrome in bipolar patients taking risperidone plus lithium.Design:a 12 weeks double-blind, randomized , placebo-controlled trial. 40 adolescents aged 11 to 17 years with Bipolar disorder will receive Risperidone (plus lithium combined with either placebo (N=20) or 3 mg/day of melatonin(N=20) for 12 weeks. Parameters measured would be: weight, height, blood pressure, HDL, LDL, fasting blood sugar at baseline and at week 6 and 12intervention. Depression and mania severity will be measured accordingly at the same times mentioned by Hamilton Depression scale and Young mania rating Scale respectively .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208071556N44
Registration date:2012-08-26, 1391/06/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-08-26, 1391/06/05
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate: a randomized,double blind, placebo-controlled clinical trial
Public title
Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Bipolar Disorder type 1( according to DSM-IV criteria) 2-age between 11-17 3- weight within normal range
Exclusion criteria:
1-Active medical disease including seizure, hepatic disease, organic brain syndromes, Diabetes 2-history of metabolic syndrome 3-using appetizers such as antihistamines or appetite suppressors like amphetamines 4-heavy consumption of Xantine drivatives( tea, coffee and cacao)
Age
From 11 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2012-08-04, 1391/05/14
Ethics committee reference number
18139
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Body Mass Index
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Calculated as body weight (kg) divided by the height in meters squared.
2
Description
High-density lipoprotein (HDL)
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Biochemistry
3
Description
Low- density lipoprotein
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Biochemistry
4
Description
Fasting blood sugar
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Biochemistry
5
Description
TG
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Biochemistry
6
Description
Blood pressure
Timepoint
Baseline and weeks 6-12 after beginig of treatment
Method of measurement
Mercury sphygmomanometer.
Secondary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 6 and 12 after startin treatment
Method of measurement
By Hamilton depression rating scale
2
Description
Severity of mania
Timepoint
Baseline and weeks 6 and 12 after startin treatment
Method of measurement
By Young mania rating scale
Intervention groups
1
Description
Intervention group:Tablet Risperidone plus lithium plus melatonin( 3 mg/day) for 12 weeks
Category
Treatment - Drugs
2
Description
Tablet Risperidone plus lithium plus placebo for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
South Kargar Sreeet, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital; South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital-South Karegar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)