This study aims to measure the effect of liothyronin on mood and alertness of patients with major depression who receive ECT. A total of fifty patients with major depression based on DSMIV who are candidate to treat with ECT and are between 18 to 60 years were included into the study and after exclusion of patients with severe cardiac disease, thyroid problems, and organic brain diseases, and those with pregnancy and addiction, the patients were randomly assigned into intervention or control group. Both group; receive six sessions of the standard bilateral ECT. One day before the start of the ECT, the patients in the intervention group receive 50 microgram liothyronin, daily, until the end of sixth ECT. The patients in the control group receive placebo over this period. Mood condition will be measured by using Hamilton test and Wechsler test is used to measure alertness, before treatment, after the third ECT, and after the sixth ECT. The results will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011075127N1
Registration date:2011-01-14, 1389/10/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-14, 1389/10/24
Registrant information
Name
Abbas Masoudzadeh
Name of organization / entity
Zare hospital, Mazandaran University of Medical Sciense,
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5109
Email address
amasoudzadeh@mazum.ac.ir
Recruitment status
Recruitment complete
Funding source
Psychiatry and Behavioral Sciences Research Center of Mazandaran University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of liothyronine efficacy add to ECT on response to treatment and memory impairment of patients with major depressive disorder
Public title
The effect of liothyronin on electeroconvulsive therapy in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: MMD patients according to DSM IV-TR, presence of indication of ECT diagnosed by a psychiatrist, signing the informed consent
Exclusion criteria: pregnancy, severe cardiac disease, thyroid dysfunction, failure to follow up
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Mazandaran University of Medical Sciense
Street address
Moallem Square
City
Sari
Postal code
Approval date
2010-11-24, 1389/09/03
Ethics committee reference number
87-103
Health conditions studied
1
Description of health condition studied
severe depressive episode without psychotic symptoms
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
2
Description of health condition studied
Severe depressive episode with psychotic symptoms
ICD-10 code
F32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
Primary outcomes
1
Description
cognitive change
Timepoint
before treatment, after the third ECT, and after the sixth ECT
Method of measurement
wechsler test
Secondary outcomes
1
Description
mood change
Timepoint
before treatment, after the third ECT, and after the sixth ECT
Method of measurement
hamilton test
Intervention groups
1
Description
Six sessions of the standard bilateral ECT as well as 50 microgram liothyronin, daily, since a day before the start of the ECT until the end of sixth ECT
Category
Treatment - Drugs
2
Description
Six sessions of the standard bilateral ECT as well as placebo, daily, since a day before the start of the ECT until the end of sixth ECT
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Burns and Psychiatric Hospital
Full name of responsible person
Dr Mahdi Poorasghar
Street address
Neka road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center of Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Farnia
Street address
Zare hospital, Neka road
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Psychiatry and Behavioral Sciences Research Center of Mazandaran 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
Psychiatry and Behavioral Sciences Research Center of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Taha Yahyavi
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Zare hospital, Neka road
City
Sari
Postal code
Phone
+98 15 1326 9143
Fax
Email
seyyedtaha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Dr. Abbas Masoudzadeh
Position
psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Zare hospital, Neka road
City
Sari
Postal code
Phone
+98 15 1328 5109
Fax
Email
amasoudzadeh@mazum.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Dr. Seyyed Taha Yahyavi
Position
resident of psychiatry
Other areas of specialty/work
Street address
Zare hospital, Neka road
City
Sari
Postal code
Phone
+98 15 1326 9143
Fax
Email
seyyedtaha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)