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Effects of Electric Electroconvulsive Therapy on Cognitive Functions in Patients with Depressive, Bipolar and Schizophrenic Disorders

Protocol summary

Summary
Study Objective: Effects of Electroconvulsive therapy on cognitive functions in patients with depressive, bipolar and schizophrenic disorders Design study: pre-test, intervention, post- test Method of study include: Study population: patients with depressive, bipolar and schizophrenic disorders Inclusion criteria: diagnosis of schizophrenia and major depressive and bipolar disorders by psychiatrist according DSM-IV criteria, Having literacy and having enough vision Exclusion criteria: History of alcohol and drug abuse, received ECT during the previous year, other physical illness or psychiatric diagnosis Sample size: 90 patients with depressive disorders, schizophrenia and mania (30 patients in each group) Intervention: Electroconvulsive therapy three sessions a week Intervention and outcomes study: patients one day before of Electroconvulsive therapy and one day after its end, by a set of computerized cognitive tests including auditory reaction time, visual reaction time, verbal memory, visual memory, motor function and Wisconsin card sorting are assessed.

General information

Acronym
ECT
IRCT registration information
IRCT registration number: IRCT201105246585N1
Registration date: 2011-06-30, 1390/04/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Narges Fouladivanda
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 6534
Email address
fouladivanda.narges@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University
Expected recruitment start date
2008-05-04, 1387/02/15
Expected recruitment end date
2009-05-05, 1388/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Electric Electroconvulsive Therapy on Cognitive Functions in Patients with Depressive, Bipolar and Schizophrenic Disorders
Public title
Cognitive Effects of Electroconvulsive Therapy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia and major depressive and bipolar disorders by psychiatrist according DSM-IV criteria, Having literacy and having enough vision Exclusion criteria: History of alcohol and drug abuse, received ECT during the previous year, other physical illness or psychiatric diagnosis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University
Street address
Shiraz University, Eram Square, Shiraz
City
Shiraz
Postal code
Approval date
2008-04-29, 1387/02/10
Ethics committee reference number
ت/ 384

Health conditions studied

1

Description of health condition studied
major depressive disorder
ICD-10 code
F33, F33.2
ICD-10 code description
Recurrent depressive disorder, Recurrent depressive disorder, current episode severe without psychotic symptoms , Recurrent depressive disorder, current episode severe with psychotic symptoms

2

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

3

Description of health condition studied
bipolar disorder
ICD-10 code
F31, F31.1
ICD-10 code description
Bipolar affective disorder, Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms

Primary outcomes

1

Description
verbal memory
Timepoint
One day before and one day after the end of treatment
Method of measurement
verbal memory task

2

Description
Auditory reaction time
Timepoint
One day before and one day after the end of treatment
Method of measurement
Auditory reaction time task

3

Description
Visual reaction time
Timepoint
One day before and one day after the end of treatment
Method of measurement
Visual reaction time task

4

Description
visual memory
Timepoint
One day before and one day after the end of treatment
Method of measurement
Benton visual memory task

5

Description
executive function
Timepoint
One day before and one day after the end of treatment
Method of measurement
Wisconsin Card Sorting Task

6

Description
motor function
Timepoint
One day before and one day after the end of treatment
Method of measurement
motor function task

Secondary outcomes

empty

Intervention groups

1

Description
electroconvulsive therapy three sessions a week
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Hospital Psychiatry
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Razi Hospital Psychiatry
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University
Full name of responsible person
Dr. Mohammad Ali Goodarzi
Street address
Faculty of Education and Psychology, Shiraz University, Eram Square, Shiraz
City
Siraz
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 of Shiraz University
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
Yasouj University of Medical Sciences
Full name of responsible person
Narges Fouladivanda
Position
M.A Clinical Psychology
Other areas of specialty/work
Street address
Student Counseling Center, Medical Sciences University, Keshavarzi Boulevard, Yasouj
City
Yasouj
Postal code
Phone
+98 74 1222 3916
Fax
Email
fouladivanda.narges@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Narges Fouladivanda
Position
M.A Clinical Psychology
Other areas of specialty/work
Street address
Student Counseling Center, Medical Sciences University, Keshavarzi Boulevard, Yasouj
City
Yasuoj
Postal code
Phone
+98 74 1222 3916
Fax
+98 74 1222 6715
Email
fouladivanda.narges@yums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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