Comparison of the improvement score of cognitive function due to Electroconvulsive therapy in patients with bipolar disorder in two groups receiving melatonin and placebo.
Design
Clinical trial with a control group, with parallel groups, 3 blind strains, randomized, phase 3 on 46 patients. Block randomization method was used for randomization.
Settings and conduct
The current study is a Triple blinded randomized clinical trial. In this study, 46 patients over 18 years of age suffering from bipolar disorder treated with Electroconvulsive therapy were randomly assigned to two drug and placebo groups. Patients in the drug group will receive 3 mg melatonin tablets in the form of 1 oral tablet 2 times a day from 24 hours before the start of Electroconvulsive therapy to 24 hours after the end of Electroconvulsive therapy.Only the ward nurse will be aware of the patient's treatment group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age with bipolar disorder, and at the beginning of treatment with Electroconvulsive therapy.
Exclusion criteria: schizophrenia, psychiatric illnesses with other mental illnesses,liver or kidney failure, history of seizures, drug or alcohol use, history of melatonin allergy, Pregnancy, breastfeeding.
Intervention groups
In this study, 46 patients over 18 years of age with bipolar disorder treated with Electroconvulsive therapy who meet the inclusion criteria were randomly assigned to two drug and placebo groups. Patients in the drug group will receive 3 mg melatonin tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of Electroconvulsive therapy to 24 hours after the end of Electroconvulsive therapy.
Main outcome variables
The effect of melatonin on cognitive impairment caused by Electroconvulsive therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054879N5
Registration date:2023-05-27, 1402/03/06
Registration timing:registered_while_recruiting
Last update:2023-05-27, 1402/03/06
Update count:0
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-26, 1402/03/05
Expected recruitment end date
2023-11-26, 1402/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Melatonin on Cognitive Performance Impairment During Electro Convulsive Therapy in Patients with Bipolar Disorder
Public title
Effect of Melatonin on Cognitive Performance Impairment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age who are diagnosed with bipolar according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria and based on the diagnosis of a psychiatrist, and at the beginning of ECT treatment, refer to Rasht Shafa Hospital.
Exclusion criteria:
Schizophrenia
Drug Abusers
Psychiatric diseases with other mental illnesses
Bradyarrhythmia
Liver or kidney failure
History of seizures
Drug or alcohol use
History of asthma or bronchospasm
History of allergy to melatonin
Pregnancy
Breastfeeding
Currently uncontrolled hypertension
Active peptic ulcer
Receiving nitroglycerin
History of severe skin disease such as Steven Johnson.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The case group was named A and the control group was named B. Random blocking is in this way that research units were assigned number 1 to 46 in order. Then a table with 23 rows named block and each block had 2 parts and each part was labeled with A and
B was named, considered. In the next step, the numbers will be placed in each house in order. After all the numbers were placed in the blocks, the people who had numbers in house A received the intervention drug, and the people who
had numbers in house B, they were considered as the control group.
The website https://www.sealedenvelope.com is used for randomization. The treatment group of each patient will be determined only after randomization.
Allocation Concealment method:
Opaque envelopes sealed with a random sequence (snose) are used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The treatment group of each patient will be determined only after randomization. The participants and the medical doctors responsible for taking care of the health of the patients and the researcher will be blinded and will not know about the treatment group. Only the ward nurse will be aware of the patient's treatment group and will open the relevant envelope. In addition, the research evaluators and statistics experts will be blinded to the treatment group of patients. In order to hide the random allocation, the Numbered Sequentially Envelopes method is used: envelopes sealed, opaque.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Rasht, Namjo St., Shahid Siadati St., in front of 17 Shahrivar Hospital, Research and Technology Deputy
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.GUMS.REC.1402.080
Health conditions studied
1
Description of health condition studied
Bipolar
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
The primary measurable outcome in this study is the evaluation of cognitive disorders caused by electroshock therapy in bipolar patients treated with melatonin by the Mini-Mental State Examination questionnaire, which is evaluated before and after 12 sessions of electroshock therapy.
Timepoint
Before and after 12 sessions of electroshock therapy.
Method of measurement
Mini-Mental State Examination questionnaire
Secondary outcomes
1
Description
The examination of changes in systolic and diastolic blood pressure
Timepoint
Before and after each session
Method of measurement
The blood pressure of the patients are checked and measured by the doctor and the researcher every time the patient visits.
2
Description
Check heart rate changes
Timepoint
Before and after each session
Method of measurement
The heart rate of the patients is checked and measured by the doctor and the researcher every time the patient visits.
3
Description
Investigation of possible drug side effects
Timepoint
Before and after each session
Method of measurement
Patients are examined by doctors and researchers at each visit.
Intervention groups
1
Description
Intervention group: 23 Patients in the intervention group will receive 3 mg melatonin tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of ECT to 24 hours after the end of ECT.
Category
Treatment - Drugs
2
Description
Control group:23 Patients in the control group will receive placebo tablets manufactured by Simorgh Daru Company in the form of 1 oral tablet 2 times a day from 24 hours before the start of Electroconvulsive Therapy to 24 hours after the end of Electroconvulsive Therapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Rasht Hospital
Full name of responsible person
Amirmahdi Rezapour
Street address
Rasht - Mosli Square - 15 Khordad St. - Shafa Medical Education Center
City
Rasht
Province
Guilan
Postal code
41936-55599
Phone
+98 13 3366 2325
Email
shafahospitalrasht@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Rasht, Namjo St., Shahid Siadati St., in front of 17 Shahrivar Hospital, Research and Technology Deputy
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3334 5308
Email
Oia.int@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Rasht-Namjo-in front of Azadi Stadium-No. 25 Nazari Alley
City
Rasht
Province
Guilan
Postal code
4144673857
Phone
+98 13 3333 3380
Email
amirmahdi.rezapour77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the approval of the ethics committee of Guilan University of Medical Sciences, in order to respect the privacy of patients, there is no plan to publish the results of patients.
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