Comparing the effect of electroconvulsive therapy (ECT) with or without sodium valproate on cognitive impairments and treatment response in patients with bipolar disorder with manic episode: a double blind randomized clinical trial
Objectives: To compare effect of electroconvulsive therapy (ECT) with or without sodium valproate on cognitive impairments and treatment response in patients with bipolar disorder with manic episode.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients with bipolar disorder with manic episode who will refer to Baharan Hospital in Zahedan during the study period will be enrolled into the trial.
Inclusion criteria: bipolar disorder with manic episode; Indication of electroconvulsive therapy.
Exclusion criteria: having other psychiatric disorders; contraindication for ECT; drug abuse; using anti-convulsion medications beside sodium valproate.
Intervention group: electroconvulsive therapy three times a week for two weeks plus tablet sodium valproate 200 mg three times a day for one month.
Control group: electroconvulsive therapy three times a week for two weeks plus tablet placebo three times a day for one month.
Primary outcome: (a) assessing cognitive impairments before and one month after treatment using Minimal Mental State Exam (MMSE); (b) assessing severity of mania before and one month after treatment using Young Mania Rating Scale (YMRS).
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608049014N108
Registration date:2016-08-14, 1395/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-14, 1395/05/24
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
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of electroconvulsive therapy (ECT) with or without sodium valproate on cognitive impairments and treatment response in patients with bipolar disorder with manic episode: a double blind randomized clinical trial
Public title
Comparing the effect of electroconvulsive therapy (ECT) with or without sodium valproate on cognitive impairments and treatment response in patients with bipolar disorder with manic episode
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: bipolar disorder with manic episode; Indication of electroconvulsive therapy.
Exclusion criteria: having other psychiatric disorders; contraindication for ECT; drug abuse; using anti-convulsion medications beside sodium valproate.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
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 Zahedan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences, ِDaneshgah Ave.
City
Zahedan
Postal code
سیستان و بلوچستان
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
IR.ZAUMS.REC.1395.42
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
cognitive impairment
Timepoint
before and one month after treatment
Method of measurement
using Minimal Mental State Exam (MMSE)
2
Description
severity of mania
Timepoint
before and one month after treatment
Method of measurement
using Young Mania Rating Scale (YMRS)
Secondary outcomes
empty
Intervention groups
1
Description
electroconvulsive therapy three times a week for two weeks plus tablet sodium valproate 200 mg three times a day for one month
Category
Treatment - Drugs
2
Description
electroconvulsive therapy three times a week for two weeks plus tablet placebo three times a day for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan Hospital
Full name of responsible person
Hasan Golabchifard
Street address
Baharan Hospital, Imam Komeini Ave.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr Refighdoost
Street address
Zahedan University of Medical Sciences, Daneshgah Ave
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Zahedan 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
Baharan Hospital
Full name of responsible person
Hasan Golabchifard
Position
Medical Student
Other areas of specialty/work
Street address
Baharan Hospital, Imam Komeini Ave.
City
Zahedan
Postal code
Phone
+98 54 3351 3777
Fax
Email
Dr.golabchi2016@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baharan Hospital
Full name of responsible person
Dr Maryam Lashkaripoor
Position
Psychiatrist
Other areas of specialty/work
Street address
Baharan Hospital, Imam Komeini Ave.
City
Zahedan
Postal code
Phone
+98 54 3351 3777
Fax
Email
Dr_lashkaripour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)