Comparison of the side effects of treatment with Duloxetine plus Electroconvulsive therapy and Sertraline plus Electroconvulsive therapy in patients with treatment resistant major depression
Assurance of safety of therapeutic combination of duloxetine plus electroconvuisive therapy
Design
The clinical trial in phase I is allocated to two 16 member groups selected by randomization software treated with duloxetine and serteraline, after making sure of existence of inclusion criteria and lack of exclusion criteria Electrocardiography is taken from each of them and Electroconvulsivetherapy is applied. During ECT the duration of the seizures are recorded. Then the EKG is repeated again and any complaint including nausea, headache and body pain is asked and recorded.
Before and after seizure cognitive state of any individual is evaluated by MMSE. Any differences in all variables are recorded and compared between the two groups.
Settings and conduct
The patients are randomly chosen among treatment resistant depressed patients candidates for ECT admitted in Shiraz Ebne Sina Hospital. Surveillance of possible side effects recorded in the intervention group.
Participants/Inclusion and exclusion criteria
Treatment resistant depression, Age between 20 to 60 years without other medical condition, neurological disorder, cardiovascular disease, contraindication to duloxetine and/ or Sertraline, Using other antidepressant(s) or drugs with possible effect on ECT and any contraindication for ECT, Serteraline and/or duloxetine
Intervention groups
Electroconvulsive therapy plus duloxetine group, Electroconvulsive therapy plus serteraline group
Main outcome variables
Convulsion duration; electrocardigram; headache; body pain; nausea; cognition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181204041847N1
Registration date:2018-12-17, 1397/09/26
Registration timing:registered_while_recruiting
Last update:2018-12-17, 1397/09/26
Update count:0
Registration date
2018-12-17, 1397/09/26
Registrant information
Name
Ebrahim Moghimi-Sarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 9319
Email address
moghimie@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-10, 1397/09/19
Expected recruitment end date
2019-02-10, 1397/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the side effects of treatment with Duloxetine plus Electroconvulsive therapy and Sertraline plus Electroconvulsive therapy in patients with treatment resistant major depression
Public title
Side effects of Duloxetine plus Electroconvulsive therapy in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Treatment resistance depression diagnosed by psychiatrist based on DSM5 criteria
Exclusion criteria:
Other medical condition
Neurological disorder
Cardiovascular disease
Contraindication to duloxetine and/ or Sertraline
Current using other antidepressant(s) or drugs with possible effect on ECT
Any contraindication for ECT
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with bio-statistical software
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 Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.60
Health conditions studied
1
Description of health condition studied
Treatment resistance depression diagnosed by psychiatrist based on DSM5 criteria
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Convulsion duration
Timepoint
During ECT
Method of measurement
Time duration with timer
2
Description
Electrocardiogram
Timepoint
Before and after each ECT
Method of measurement
Electrocardiogram
3
Description
Headache
Timepoint
After each ECT
Method of measurement
History
4
Description
Cognition
Timepoint
Before and after ECT
Method of measurement
Mini mental status examination
5
Description
Body pain
Timepoint
After each ECT
Method of measurement
History
6
Description
Nausea
Timepoint
After each ECT
Method of measurement
History
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Duloxetine plus Electroconvulsive therapy
Category
Treatment - Drugs
2
Description
Control group: Serteralin plus Electroconvulsive therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina Hospital
Full name of responsible person
Ebrahim Moghimi-Sarani
Street address
Hafez Street
City
Shiraz
Province
Fars
Postal code
7144676549
Phone
+98 71 3227 1387
Email
moghimie@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim MOGHIMI-Sarani
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
moghimie@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi-Sarani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
7144676549
Phone
+98 71 3227 1387
Email
moghimie@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi-Sarani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
7146676549
Phone
+98 71 3227 1387
Email
moghimie@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi-Sarani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez stret
City
Shiraz
Province
Fars
Postal code
7146676549
Phone
+98 71 3227 1387
Email
moghimie@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of personal Data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only a part of data including major outcomes are shared.
When the data will become available and for how long
6 month after the publication of results
To whom data/document is available
Publishing of the data can be confidential submitted by written request of the ethics committee
Under which criteria data/document could be used
Only for Ethics Committee
From where data/document is obtainable
Ebrahim moghimi-Sarani
What processes are involved for a request to access data/document