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Effect of transcranial direct current stimulation on sertraline composition on the severity of symptoms of obsessive-compulsive disorder

Protocol summary

Study aim
Determining the effect of transcranial direct current stimulation (TDCS) in the combination of sertraline drug on the severity of symptoms of obsessive and compulsive disorder
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 50 patients and randomization through random allocation rule
Settings and conduct
Amirkabir Hospital; Patients meeting the study criteria will be randomly assigned to one of the two treatment groups through random allocation. Based on the sequences (double-blind), people in the intervention group (25 people) undergo TDCS stimulation and in the control group (25 people) undergo Sham stimulation (20 minutes). The anode is connected in the left dorsolateral prefrontal region and the cathode is connected in the right orbitofrontal region. After 8 sessions and 16 sessions, and then one month after the 16th session, the patients are re-evaluated through the Padua questionnaire and then they are subjected to statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion:Minimum education, age above 18 years and below 65 years, have obsessive thoughts of pollution, harming themselves and others or obsessive behavior, their disorder severity is moderate or severe and while taking sertraline. exclusion:Recent history of brain surgery, brain abnormalities, devices implanted in the skull, having a hearing aid that cannot be removed, active skin lesions on the scalp, history of migraines and seizures, unstable medical or psychiatric conditions , use current interventional drugs or drug use, patients treated with any type of neuromodulation therapy (during the past 3 months)
Intervention groups
One group (intervention group) is subjected to TDCS stimulation and one group (control group) is subjected to Sham stimulation and then compared.
Main outcome variables
Severity of obsessive and compulsive disorder symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230922059487N1
Registration date: 2023-11-17, 1402/08/26
Registration timing: prospective

Last update: 2023-11-17, 1402/08/26
Update count: 0
Registration date
2023-11-17, 1402/08/26
Registrant information
Name
Mohammad ali Hossein tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3861 4254
Email address
m.hosseintehrani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-08-17, 1403/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of transcranial direct current stimulation on sertraline composition on the severity of symptoms of obsessive-compulsive disorder
Public title
Transcranial direct current stimulation and sertraline on obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with obsessive-compulsive disorder with minimal literacy at the level of reading and writing Patients with obsessive-compulsive disorder aged over 18 and under 65 years Patients suffering from obsessive-compulsive disorder who, based on the Padua questionnaire, have obsessive thoughts of contamination, harming themselves and others, or self-control Patients suffering from obsessive-compulsive disorder whose severity is moderate or severe based on the Padua questionnaire Patients with obsessive-compulsive disorder who took sertraline (at least 100 mg) during the study.
Exclusion criteria:
Patients with a recent history of brain surgery, neurological conditions associated with brain abnormalities (such as traumatic brain injury, recent stroke and tumor), devices implanted in the skull, having hearing aids that are not removable, active skin lesions on the scalp History of migraine, epilepsy and convulsions, unstable medical or psychiatric conditions (such as psychotic disorders, bipolar disorder, suicidal thoughts or attempted suicide in the last 4 weeks) Patients with current use of benzodiazepines, anticonvulsants, lithium carbonate, psychostimulants, dextromethorphan, pseudoephedrine, or recreational drug use Patients treated with any type of neuromodulation treatment (such as ECT, transcranial magnetic stimulation or TDCS) during the last 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to one of two treatment groups through random allocation rule (pot method): 1- Active TDCS 2- Sham TDCS. In this way, after determining the sample size (50 patients), we prepare 25 cards for the intervention group and 25 cards of the same shape for the control group and put them in a container, and then we take out the cards in turn without replacement and a We create a sequence of the intervention and control group, which is done by the associate psychologist for randomization and blinding, and based on the sequences, the patients are stimulated by active or sham TDCS.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double blind. The researcher and participants will be blinded to the group allocation. Each participant will be assigned an identification number (ID) based on the sequence created (active or sham conditions) according to the random assignment method. The supervisor (a third party) creates an ID number for each participant and uploads them to a device that the researcher does not have access to during the study. When double-blind mode is activated on the device, all unnecessary information is hidden on the monitor, leaving the researcher unaware of which protocols refer to active stimulation and which protocols are sham. When a participant arrives for their session, the operator selects a protocol number that matches the participant ID number on the TDCS machine, and the researcher does not know which condition they have been assigned to
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176589
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.ARAKMU.REC.1402.115

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Obsessive-practical score in the Padua questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), after 8 sessions, 16 sessions and then one month after the 16th session
Method of measurement
The Padua questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: This group receives passive TDCS only. In this group, there are 25 people who receive passive TDCS only, in a room in a psychiatric clinic that is equipped with equipment to check vital signs and under the supervision of the psychologist who performs this treatment and the assistant. Neuropsychiatry receive passive TDCS. In passive stimulation, the same things are done as for active stimulation, the only difference being the current that reaches the patient. To do this, patients are first told to make the cathode and anode areas as thin as possible. If the patients are stable, first the cathode and then the anode are connected through a sponge pad soaked in normal saline in the left dorsolateral prefrontal region and the cathode in the right orbitofrontal region. The control group is subjected to passive TDCS current for 20 minutes per session. After 8 sessions and 16 sessions and then one month after the 16th session, the patients are re-evaluated (by a psychiatric assistant) through the Padua questionnaire, and the information received from them is recorded in the relevant checklist.
Category
Treatment - Devices

2

Description
Intervention group: This group is treated with active TDCS. There are 25 people in this group who receive active TDCS in a room in a psychiatric clinic that is equipped with equipment for checking vital signs and under the supervision of a psychologist who performs this treatment and a neurosurgeon. Psychiatry receive active TDCS. To do this, patients are first told to make the cathode and anode areas as thin as possible. If the patients are stable, first the cathode and then the anode are connected through a sponge pad soaked in normal saline in the left dorsolateral prefrontal region and the cathode in the right orbitofrontal region. The intervention group is subjected to active TDCS flow for 20 minutes in each session. After 8 sessions and 16 sessions and then one month after the 16th session, the patients are re-evaluated (by a psychiatric assistant) through the Padua questionnaire, and the information received from them is recorded in the relevant checklist.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Mohammad Ali Hossein Tehrani
Street address
Amirkabir hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4717
Email
m.hosseintehrani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dawood Hekmat Po
Street address
Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
dr_hekmat@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Ali Hossein Tehrani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.11, Al Ghadir Buildings, Mohajeran Town
City
Arak
Province
Markazi
Postal code
3991793736
Phone
+98 86 3861 4254
Email
m.hosseintehrani@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Ali Hossein Tehrani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.11, Al Ghadir Buildings, Mohajeran Town
City
Arak
Province
Markazi
Postal code
3991793736
Phone
+98 86 3861 4254
Email
m.hosseint@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Ali Hossein Tehrani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.11, Al Ghadir Buildings, Mohajeran Town
City
Arak
Province
Markazi
Postal code
3991793736
Phone
+98 86 3861 4254
Email
m.hosseintehrani@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Since 2026
To whom data/document is available
Medical students and researchers
Under which criteria data/document could be used
Scientific and therapeutic use is unimpeded
From where data/document is obtainable
You can contact Dr. Mohammad Ali Hossein Tehrani located at Amir Kabir Arak Medical Center with mobile number 09128667110 or send a message to his email at ahosseint@yahoo.com
What processes are involved for a request to access data/document
The applicant can make his or her request through the given email or phone call, after 3 months of the application, the result will be notified to the applicant and the approved items will be sent to the applicant
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