The effectiveness of omega-3 adjuvant therapy toElectroconvulsive therapy (ECT) in bipolar patients in a manic episode
Design
A randomized clinical trial with the parallel control group, double-blind; Phase 2-3, on 50 patients, the patients will be randomly assigned to intervention and control groups using block randomization.
Settings and conduct
This study is performed on bipolar patients in the acute phase of mania which, according to the doctor's opinion, needed to receive ECTin Farshchian Hospital in Hamadan. The patient and the examining physician will not be aware of the patient's type of drug treatment so the study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Bipolar patients in the acute phase of mania who, according to the physician, needed ECT; Age greater than or equal to 18; Young Mania Rating Scale greater than or equal to 20; Having at least fifth-grade education
Exclusion criteria: Psychiatric disorders except for Bipolar Disorder;Pregnancy or breastfeeding; Having a history of substance abuse in the last 2 weeks or addiction in the previous 2 months; Having a systemic disease
Intervention groups
Intervention group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with 100 mg omega-3 capsules(manufactured by Zahravi company) for 4 weeks.
Control group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with a placebo (manufactured by Zahravi company) for 4 weeks.
Main outcome variables
Cognitive function, sleep quality, Young Mania questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N26
Registration date:2022-09-13, 1401/06/22
Registration timing:registered_while_recruiting
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of omega-3 adjuvant therapy to Electroconvulsive therapy (ECT) in bipolar patients in a manic episode
Public title
The effect of adding omega-3 in bipolar patients during manic period requiring ECT.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bipolar patients in the acute phase of mania who, according to the physician, needed ECT
Age greater than or equal to 18
Young Mania Rating Scale greater than or equal to 20
Having at least fifth grade education
Exclusion criteria:
Psychiatric disorders except Bipolar Disorder
Pregnancy or breastfeeding
Having a history of substance abuse in the last 2 weeks or addiction in the last 2 months
Having a systemic disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The form of the drug and the placebo are completely the same, so the patient and the examining physician will not be aware of the patient's type of drug treatment, so the study will be performed in a double-blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.UMSHA.REC.1401.325
Health conditions studied
1
Description of health condition studied
Bipolar Disorder, current episode manic severe with psychotic features
ICD-10 code
F31.2
ICD-10 code description
Bipolar Disorder, current episode manic severe with psychotic features
Primary outcomes
1
Description
mania symptoms
Timepoint
Before the intervention, after the fourth and eighth sessions of ECT.
Method of measurement
Young Mania Rating Scale (YMRS)
2
Description
Cognitive function
Timepoint
Before and after the intervention
Method of measurement
Cognitive function Test by using Montreal Cognitive Assessment
3
Description
sleep quality
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with 100 mg omega-3 capsules (manufactured by Zahravi company) as a single daily oral dose for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions.
Category
Treatment - Drugs
2
Description
Control group: 25 patients with bipolar disorder in the mania phase are treated with electroshock therapy with a placebo (manufactured by Zahravi company) for 4 weeks. The number of electroshock therapy sessions is 8 sessions, which are done on a day in the middle under standard conditions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Ali Ghaleiha
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
alighaleih@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_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
Khadijeh Arabloo
Position
Resident Psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
Kharabloo1358@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
alighaleih@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khadijeh Arabloo
Position
Resident Psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
Kharabloo1358@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