Evaluation of the effect of repeated transcranial magnetic stimulation (rTMS) in reducing the percentage of suicidal ideation in depressed patients compared with the control group.
1.Determining the effectiveness of repetitive transcranial magnetic stimulation in reducing the severity of suicidal ideation in depressed patient in comparsion with control group2.Reducing Hospitalization density of patients3.Reducing hospitalization costs
Design
A controlled, double-blind, randomized controlled clinical trial on 40 hospitalized depressed patients with suicidal ideation who used random allocation law for randomization
Settings and conduct
The study was performed on 40 depressed patients admitted to Iran Psychiatric Hospital who have suicidal ideation. All patients receive antidepressant medication and are randomly divided into intervention and control groups to evaluate the effect of transcranial magnetic stimulation. Blinding is when patients and the main researcher do not know whether the magnetic stimulation is placebo or real.
Participants/Inclusion and exclusion criteria
Incusion criteria:patient with major depression/dysthymic/Double depression with suicidal ideation
Exclusion criteria:Less than 18 years old/Metal objects in the skull/Pregnant woman/History of seizures/Addiction/Borderline Personality disorder/Dementia
Intervention groups
Among depressed patient with suicidal ideation,40 eligible individuals with suicidal ideation Were selected and randomly divided into twio group of 20, intervention and control.Transcranial magnetism is Examined in reducing suicidal ideation
Main outcome variables
Decrease in suicide score in Beck questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201026049155N1
Registration date:2021-04-25, 1400/02/05
Registration timing:registered_while_recruiting
Last update:2021-04-25, 1400/02/05
Update count:0
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
MEHDI HOSEINI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8824
Email address
dr.hoselni7252@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of repeated transcranial magnetic stimulation (rTMS) in reducing the percentage of suicidal ideation in depressed patients compared with the control group.
Public title
Evaluation of the effect of repeated transcranial magnetic stimulation (RTMS) in reducing the percentage of suicidal ideation in depressed patients compared with the control group.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depression with suicidal ideation
Dysthymic patients with suicidal ideation
Patients with double depression with suicidal ideation
Exclusion criteria:
Metal objects in the skull
Pregnant lady
History of convulsions
Received an electric shock in a recent month
Psychotic depression
Postpartum Depression
Addiction
Mentally retarded
Borderline personality disorder
Dementia
Use of bupropion and methylphenidate
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
4
Beck Depression and Suicide Questionnaire is completed once before the start of treatment and once after the end of the third session of treatment and once at the end of the sixth session and once a month after treatment.
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule. :Depending on the sample size and using the random allocation method, the letter A is written on 20 pieces of paper and the letter B is written on 20 pieces of paper and the papers are folded so that the letters A and B are not clear. The papers are poured into a container and mixed, and
by referring to any depressed person with suicidal thoughts accidentally opens one of the folded papers.
if A:as a real magnetic stimulation and if B: was a placebo for patients, finally out of a sample of 40 people, 20 would randomly receive real magnetic stimulation and 20 would receive a placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
On the day after hospitalization of a depressed patient with suicidal ideation in the hospital, Beck Depression and Suicide Questionnaires are completed by the researcher. The researcher does not know about the type of intervention that real rTms or placebo is performed. The patient is sent to the rTms room .In this case, one of the folded papers is opened randomly by the operator of the machine, and if it was A, 6 sessions of real magnetic stimulation, and if it was B, 6 sessions of placebo is done for patients.
Patient selection is done randomly by the device operator. Patients and researchers do not know whether the magnetic stimulation is real or Placebo light is sent by the magnetic excitation operator, but the placement of the coil of the device is 90 degrees, which prevents the waves from reaching the skull.
The only person who knows the real thing or placebo is the device operator who writes the letter A or B in the relevant form next to the patient's name. Similarly, for 40 patients, the patient's name A or B will be registered in the relevant form. Finally, the completed form is given to the third person who analyzes the information. The researcher also gives the results of the questionnaires to this person who analyzes And there is no interference in the questionnaires and statistical analysis. After the statistical analysis is done, the intervention results are notified.
Therefore, neither the researcher nor the patient is aware of the actual or placebo treatment and the study is double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran Psychiatric Hospital; Km 8 Lashgari Bivd
City
Tehran
Province
Tehran
Postal code
1398913151
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.IUMS.FMD.REC.1398.435
Health conditions studied
1
Description of health condition studied
1. Patients with major depression with suicidal ideation ,, 2. Patients with dysthymia with suicidal ideation ,, 3. Patients with double depression with suicidal ideation
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms,
Primary outcomes
1
Description
Decrease in Suicidal Score in Beck questionnaire
Timepoint
Before the intervention and after the third and sixth sessions and one month after intervention
Method of measurement
Beck Suicide Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Depressed patients with suicidal ideation for 6 sessions are given as a placebo treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). ) . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment.
Category
Treatment - Devices
2
Description
Intervention group: Depressed patients with suicidal ideation for 6 sessions are given as a real treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). ) . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran psychiatric Hospital
Full name of responsible person
seyed Mehdi Hosseini
Street address
Iran Psychiatric Hospital.km8 Lashgari Blvd
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3401
Email
dr.hoseini7252@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motovallian
Street address
Iran Psychiatric Hospital.Km 8Lashgari Blvd
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3401
Email
dr.hoseini7252@gmail.com
Grant name
Vice Chancellor for Research, Iran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatric Hospital.km 8 Lashgari Blvd
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3401
Email
dr.hoseini7252@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyd Mehdi Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatric Hospital.km8 Lashgari Blvd
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3401
Email
dr.hoseini7252@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Iran Psychiatric Hospital.km8 Lashgari Blvd
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3401
Fax
Email
dr.hoseini7252@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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 HOPS data can be shared from unidentifiable individuals
When the data will become available and for how long
Access starts in july 2022
To whom data/document is available
There are no restrictions for applicants
Under which criteria data/document could be used
Any research to help patients with psychiatric disorders is allowed
From where data/document is obtainable
Iran,Tehran,8 km of Shahid Lashgari Highway, Iran Psychiatric Hospital, Dr. Seyed Mehdi Hosseini Contact number 00989125955223
What processes are involved for a request to access data/document
Correspondence or face-to-face referral to Iran Psychiatric Hospital, telephone or correspondence to e-mail address
Comments
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