This study will be done with aim of determining the effect of daily electroconvulsive therapy (ECT) on patients with refractory schizophrenia. The present study is a non-blinded clinical trial. The study population is consisted of all patients with refractory schizophrenia that Admitted in Farabi hospital, Kermanshah. Among them 14 patients will be selected conveniently. And Will be divided into two groups (7 patients as experimental group and 7 patients as control group). Both groups will be evaluated by the Brief Psychiatric Rating Scale (BPRS) at the beginning of the study .The experimental group will be treated by ECT 6 times a week(daily) and the control group will be treated for 3 times a week (every other day). ECT will be done on non-dominant hemisphere with current of 0.9 AMPS, constant current of 450 volts, frequency of 10 to 70 Hz, pulswidth of 0.25 to 1.5 MS with duration of 0.14 to 7.99 Minute. The least number of ECT sessions will be 12sessions. Within 2 weeks before each period of ECT, patients Will be medication free in order to pass Wash out period. At the end of both periods, the patients Will be reevaluated based on the BPRS and both groups will be compared with each other. Inclusion criterion: Diagnosis of refractory schizophrenia, Exclusion criterion: Other psychiatric co-morbidity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090823705N7
Registration date:2016-11-30, 1395/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-30, 1395/09/10
Registrant information
Name
Mostafa Alikhani
Name of organization / entity
Kermanshah University of Medical Sciences - Substance Abuse Prevention Research Center
Country
Iran (Islamic Republic of)
Phone
+98 838264513
Email address
mo.alikhani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah 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
The effect of daily electroconvulsive therapy on patients with refractory schizophrenia symptoms
Public title
The effect of daily electroconvulsive therapy in patients with refractory schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of refractory schizophrenia; range of age 18-65 years old; tendency to participate in the project. Exclusion criteria : positive history of seizure or epilepsy that needed to persistent treatment; active blood Dyskrazy; leukopeny; obstructive pulmonary disease or Pulmonary emphysema; cardiovascular disease or myocardial infarction; hepatic or renal failure; urinary obstruction; closed angle glaucoma; toxic psychosis; moderate to severe mental retardation; other psychiatric co-morbidity
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
kums.rec.1394.441
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Schizophrenia symptoms
Timepoint
The beginning of the study (baseline) and end of the study (week two)
Method of measurement
Brief Psychiatric Rating Scale (BPRS)
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group will be under treatment by Electroconvulsive Therapy for 6 days a week (daily)
Category
Treatment - Drugs
2
Description
The control group ill be under treatment by for 3 times a week Electroconvulsive Therapy (every other day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr.Jalal Shakeri
Street address
Isar square, Farabi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Habib Allah Khazaie
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 0700
Fax
Email
ha_khazaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Omran Davarinejad
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 0700
Fax
Email
Odavarinejad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Koroush Hendesi
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)