The purpose of the study is to assess the effectiveness of using levothyroxine in reducing memory loss of bipolar patients as a result of electric convulsive therapy(ECT). Inclusion criteria:Diagnosis of bipolar disorder using structured clinical intetview for Dsm disorders (SCID)َ؛indication for a psychiatrist-recommended ECT ؛An age range of 18-64؛consent letter obtained from patient's parents. Exclusion criteria:Any contraindication of levothyroxine؛Comorbidity of substance or alcohol dependency؛Any organic brain disorders or mental retardation (based on patient's history, physical examination and records) or any cognitive disorders (MMSE<23) at the advent of the study؛ECT less than 6 sessions؛ECT-induced delirium؛taking none of the standard mood-stabilizing drugs (sodium valproate ,lithium carbonate nor carbamazepin)؛ taking more than one standard mood- stabilizing drug (sodium valproate ,lithium carbonate or carbamazepin)؛receiving more than one convulsion in ECT in half of the sessions؛siezure duration lower than15 seconds in more than half of the sessions؛siezure duration higher than 3 minutes even in one session؛The study population included 48, type-I bipolar patients taking prescribed ECT from September 2016 to May 2017.During the treatment,the intervention group received 0 / 1 mg of levothyroxine with the control group taking placebo. The average amount of memory loss in both groups was measured and compared using the Wechsler memory test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071012018N3
Registration date:2016-09-16, 1395/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-16, 1395/06/26
Registrant information
Name
Hossein Javdani
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1441 2002
Email address
javdanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
reasercher
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of levothyroxine on ECT Induced Memory Impairment in bipolar patients
Public title
The effect of levothyroxine on ECT Induced Memory Impairment in bipolar patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Diagnosis of bipolar disorder based on SCID questionnaire that its persian validity and reliability is confirmedَ؛Presence of ECT indication is under recommendation of psychiatrist؛Age between 18-64؛consent letter of patient's parents.Exclusion criteria:Any contraindication of levothyroxine؛Comorbidity of substance or alcohol dependence؛Any organic brain disorder or mental retardation (based on history, physical exam and patient's records) or any cognitive impairment(MMSE<23) at begining of study؛ECT less than 6 session؛ECT induced delirium؛not using at least one of standard mood stabilizers (sodium valproate ,lithium carbonate or carbamazepin)؛use more than one of standard mood stabilizers (sodium valproate ,lithium carbonate or carbamazepin)؛use more than one convulsion in ECT in at least half of sessions؛siezure duration below 15 second in more than half of sessions؛siezure duration higher thant 3 minutes in even one session؛
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University Of Medical Science
Street address
Shahid Bahonar Blv Qazvin Iran
City
Qazvin
Postal code
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
IR.QUMS.REC.1394.202
Health conditions studied
1
Description of health condition studied
BIPOLAR affective disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
memory impairment
Timepoint
Baseline and Then two weeks after completion of therapy ذغذ
Method of measurement
wecsler memory tese
Secondary outcomes
1
Description
cognitin state
Timepoint
Baseline and Then two weeks after completion of therapy ذغذ
Method of measurement
mmse
Intervention groups
1
Description
tablet levothyroxine 0.1 mg daily fasting during ECT treatment
Category
Treatment - Drugs
2
Description
Tablet Placebo(similar Levothyroxine) daily Fasting during ECT treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Seyed Majid Hoseiny Hoshyar
Street address
22 Bahman Hospital Rah_ ahan ave Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Taghi Naserpoor
Street address
Shahid Bahonar blv Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Science
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
Qazvin University of Medical Science
Full name of responsible person
Dr Seyed Majid Hoseiny Hoshyar
Position
Rezident
Other areas of specialty/work
Street address
22 Bahman Hospital Rah-ahan avenue Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 9923
Fax
Email
majidhooshyar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr Seyed Majid Hoseiny Hoshyar
Position
Rezident
Other areas of specialty/work
Street address
22 Bahman Hospital Rah-ahan avenue Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 9923
Fax
Email
majidhooshyar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr Seyed Majid Hoseiny Hoshyar
Position
Rezident
Other areas of specialty/work
Street address
22 Bahman Hospital Rah-ahan avenue Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 9923
Fax
Email
majidhooshyar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)