Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase: a double-blind randomized clinical trial
To assess the effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase
Design
This is a double-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with bipolar disorder in the manic phase who will refer to Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Bipolar disorder in the manic phase
Exclusion criteria:
Panic disorder or social phobia,
Depressive disorder,
Schizophrenia,
Alcohol or drug abuse,
History of suicide in the past year
Intervention groups
Intervention group:
Routine treatment plus melatonin tablets manufactured by Jairus Company 30 mg every night for one week and then 60 mg every night for three weeks
Control group:
Routine treatment plus placebo tablets manufactured by the School of Pharmacy, Hamadan University of Medical Sciences, one tablet every night for one week and then two tablets every night for three weeks
Main outcome variables
Primary outcome:
Quality of sleep, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N314
Registration date:2019-10-29, 1398/08/07
Registration timing:prospective
Last update:2019-10-29, 1398/08/07
Update count:0
Registration date
2019-10-29, 1398/08/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-12, 1398/08/21
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase: a double-blind randomized clinical trial
Public title
Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Bipolar disorder in manic phase
Exclusion criteria:
Panic disorder or social phobia,
Depressive disorder,
Schizophrenia,
Alcohol or drug abuse,
History of suicide in the past year
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as triple-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.UMSHA.REC.1398.609
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Quality of sleep
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
By Insomnia Severity Index (ISI)
2
Description
Quality of life
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
By Young Mania Rating Scale (YMRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus melatonin tablets manufactured by Jairus Company 30 mg every night for one week and then 60 mg every night for three weeks
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus placebo tablets manufactured by the School of Pharmacy, Hamadan University of Medical Sciences, one tablet every night for one week and then two tablets every night for three weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Zahra Ghasemian
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
zahraghasemian758@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Ghasemian
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahraghasemian758@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Davood Ahmadimoghadam
Position
Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
d.ahmadimoghadam@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available