Protocol summary

Summary
The study aimed to compare the effect of liothyronine and piracetam on three subscales of Wechsler memory test on patients under treatment with ECT, during 2008. A total of 60 patients were allocated in three groups to receive liothyronine, piracetam, or placebo from the first session of ECT until one month after the last session of ECT. Personal information, orientation, and mental control of Wechsler memory scale were tested at first, during, and one month after last session of ECT.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138805042232N1
Registration date: 2011-09-24, 1390/07/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-24, 1390/07/02
Registrant information
Name
Seyed Ghafur Mousavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2475
Email address
mousavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2008-01-21, 1386/11/01
Expected recruitment end date
2009-01-20, 1387/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Liothyronine and piracetam on prevention of ECT-induced amnesia, Noor hospital, Isfahan, Iran
Public title
Comparison of liothyronine and piracetam on ECT-induced amnesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Psychiatrist documented order of at least 4 session of ECT for the patient, Patient acceptance the collaboration, diagnosis of MDD, BD, or schizophrenia, no MR or dementia Exclusion criteria: ECT, induced delirium, less than 4 ECTs
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
Street address
Behavioral Sciences Research Center, Noor hospital
City
Isfahan
Postal code
81456-993
Approval date
2008-02-17, 1386/11/28
Ethics committee reference number
387335

Health conditions studied

1

Description of health condition studied
Ect-induced amnesia
ICD-10 code
F00, F01,
ICD-10 code description
Organic, including symptomatic, mental disorders

Primary outcomes

1

Description
Personal information
Timepoint
Before, first, 4th, and last session, & one month after last ECT session
Method of measurement
Wechsler memory scale

2

Description
Orientation
Timepoint
Before, first, 4th, and last session, & one month after last ECT session
Method of measurement
Wechsler memory scale

3

Description
Mental control
Timepoint
Before, first, 4th, and last session, & one month after last ECT session
Method of measurement
Wechsler memory scale

Secondary outcomes

1

Description
Drug side-effects
Timepoint
All sessionS of appraisal
Method of measurement
Questionnaire

Intervention groups

1

Description
Liothyronine, tab 25 mcg, 2 tab/day, since 1day before first ECT until 1 month after last ECT sessions
Category
Prevention

2

Description
Piracetm, 800 mg tab., 2 tab/day, since one day before the first session until the last month after the last sessions of ECT
Category
Prevention

3

Description
Placebo 2 tab./day, since one day before the first session until the last session of ECT
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor hospital
Full name of responsible person
Mousavi Seyed Ghafur
Street address
Noor hospital, Ostandarie Ave.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behavioral Sciences Reseach Center of Isfahan University of Medical Sciences
Full name of responsible person
Attari Abbas
Street address
Noor hospital, Ostandarie Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioral Sciences Reseach Center of Isfahan 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
Behavioral Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Mousavi Seyed Ghafur
Position
Board certified of psychitry, Executor
Other areas of specialty/work
Street address
Noor hospital, Ostandarie Ave.
City
Isfahan
Postal code
81465-993
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Behavioral Sciences Research Center of Isfashan University of Medical Sciences
Full name of responsible person
Mousavi Seyed Ghafur
Position
Associate professor/Board certified of psychiatry
Other areas of specialty/work
Street address
Noor hospital, Ostandarie Ave.
City
Isfahan
Postal code
81458-31451
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Behavioral Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Mousavi Seyed Ghafur
Position
Associate Professor/Board certified
Other areas of specialty/work
Street address
Ostandari Ave., Noor hospital
City
Isfahan
Postal code
81485-31451
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
www.mui.ac.ir

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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