Study of the effect of melatium on prevention of relapse in patients with bipolar disorder compared with placebo
Design
This study is a randomized double-blinded clinical trial with a parallel design and a control group. In this randomized study, Phase 3 will be performed on 104 patients diagnosed with bipolar disorder. Random blocking is used for randomization and participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Farabi hospital of Kermanshah, is double-blind one in that way the experimenter and patients do not know how the patient will treat and grouping . Assignment of patients to the two treatment groups will be done by the project partner. Also, patient visits will be performed at follow-up times by the project partner who is not aware of the patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 60 years; No history of chronic physical illness such as diabetes; Cardiovascular diseases, respiratory diseases and thyroid diseases; Satisfaction of patients to participate in the study; At least middle school degree; At least one year has passed since the initial diagnosis of the disease
Exclusion criteria: Sleep disorders; Simultaneously receive other non-therapeutic treatments; Chronic mental disorders, especially personality disorders based on a psychiatrist interview; Addiction to drugs; Severe side effects of the drug; Patients who need hospitalization
Intervention groups
The intervention group will receive 30 capsules of melatium (effective ingredients are 3 mg of melatonin and 600 mg of lithium per standardized capsule) every 24 hours for 12 weeks. The control group will receive 30 placebo capsules (starch with 600 mg of lithium) every 24 hours for 12 weeks.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N158
Registration date:2020-12-30, 1399/10/10
Registration timing:prospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of melatium on prevention of relapse in patients with bipolar disorder compared with placebo
Public title
Study of the effect of melatium on prevention of relapse in patients with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
No history of chronic physical illness such as diabetes
Cardiovascular diseases, respiratory diseases and thyroid diseases
Satisfaction of patients to participate in the study
At least middle School degree
At least one year has passed since the initial diagnosis of the disease
Exclusion criteria:
Sleep disorders
Simultaneously receive other non-therapeutic treatments
Chronic mental disorders, especially personality disorders based on a psychiatrist interview
Addiction to drugs
Severe side effects of the drug; Patients who need hospitalization
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Using random blocking. 26 blocks (10 blocks of 10 people, 8 blocks of 8 people, 6 blocks of 6 people, and two blocks of 2 people) will be determined and people will be randomly divided into two intervention and control groups .
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the experimenter and the subject do not know which study group (intervention or control) the patient is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
ir.kums.rec.1399.753
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
sleep quality
Timepoint
Weeks 3, 6, 9 and after the intervention
Method of measurement
Based on sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 30 capsules of melatium (effective ingredients are 3 mg of melatonin and 600 mg of lithium per standardized capsule) every 24 hours for 12 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive 30 placebo capsules (starch with 600 mg of lithium) every 24 hours for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr. Habibollah Khazaei
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 8216 0700
Email
hakhazaie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Habibollah Khazaei
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 8216 0700
Email
hakhazaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Habibollah Khazaei
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 8216 0700
Email
hakhazaie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Habibollah Khazaei
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 8216 0700
Email
hakhazaie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 25-day timeframe