Evaluation of Bumetanide’s Effect on Symptom Characteristics ( Based on YBOCS) in Patients with Resistant Obsessive Compulsive Disorder Comparing to Selective Serotonin Reuptake Inhibitors
Evaluation of bumetanide effect on symptom characteristics in patients with obsessive compulsive disorder based on yale brown obsessive compulsive disorder scale
Design
Single-Blinded, Randomized Controlled Clinical Trial,
Selected Sample Size: 31 Subject for each arm
Settings and conduct
Roozbeh Hospital- Imam Khomeini hospital Complex- National Brain Mapping Lab
The patients will be selected based on the psychiatrist diagnosis and then reassessed by the trained clinical psychologist, the primary tests including wechsler and depression/ anxiety will be done. For all the subjects, baseline assessment of disorder severity and dimensions, blood taking for gene expression and neurocognitive and neuroimaging will be done. all of these items will be reoperate after trial completion.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Confirmed diagnosis of Obsessive Compulsive Disorder which is resistant to the Selective Serotonin Reuptake Inhibitors (SSRIs)
2. Age range between 18 and 50 years
Exclusion Criteria:
1. Psychiatric Comorbidity like: Schizophrenia and bipolar disorder
2. Any History of Neurological Disorders
3. Pregnancy and Breast Feeding
4. Concurrent use of opioids, Stimulants and alcohol
5. Any History of Cardiovascular Disorders
6. Any History of Liver Related Disorders
7. Any History of Renal Disorders
7. Sulfur Sensitivity
8. Benzodiazepine use within at least previous 3 months
Intervention groups
1. Resistant Patient Group that Receive Bumetanide in addition to the background Serotonin Reuptake Inhibitors (SRIs).
2. Resistant Patient Group that Receive the standard treatment (Antipsychotics) in addition to the background Serotonin Reuptake Inhibitors (SRIs)
Main outcome variables
1. Course of Alteration in Symptom Severity in Response to the Added Medication
2. Course of Adverse Drug Reaction in Association with the Added Medication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140120016280N3
Registration date:2019-08-11, 1398/05/20
Registration timing:prospective
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Mahmoudreza Hadjighassem
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 218899111823
Email address
mhadjighassem@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Bumetanide’s Effect on Symptom Characteristics ( Based on YBOCS) in Patients with Resistant Obsessive Compulsive Disorder Comparing to Selective Serotonin Reuptake Inhibitors
Public title
Evaluation of Bumetanide’s Effect on Symptom Characteristics in Patients with Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Confirmed Diagnosis of Resistant OCD
Age range of 18-50 years
IQ level more than 80 based on Wechsler Adult Intelligence Scale
Exclusion criteria:
Comorbidities like MDD, Bipolar Disorder, Personality Disorder, Schizophrenia
Drug Adverse Effects
Pregnancy, Breast Feeding (Based on self report data and urinary detection)
Drug and alcohol use and dependance (Based on self report data and urinary detection)
Benzodiazepine use within 3 preceding months
Furesemide and other diuretic and cardiovascular drugs use
Sulfur and its derivatives sensitivity
Neurological Disorders(seizure, trauma, ischemic stroke, surgery)
Presence of MRI SCanning absolute and partial contraindications
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization process will be done using permuted block randomization with blocks in size 4. Regarding determined sample size 70, Quadratic blocks will be produced using the online website: www.sealedenvelope.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the current study will be performed within the neuropsychiatry context and the probability of bias formation and placebo effects are considerable, the main investigator that is assessor and also the author of the manuscript would be held blinded. such a way that, the primary neuropsychological assessments will be executed by the trained clinical psychologist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciencesl Sciences
Street address
13th floor, Block A, Ministry of Health and Medical Education, Simaye Iran Street, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.TUMS.VCR.REC.1397.628
Health conditions studied
1
Description of health condition studied
Obsessive Compulsive Disorder (OCD)
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Symptom (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale
Timepoint
Assessment of Severity and pattern of symptoms : 1. In the beginning of Study and before intervention, 2. 10 days after intervention, 3. 20 days after intervention, 4. 30 days after intervention, 5. 40 days after intervention, 6. 50 days after intervention, 7. 60 days after intervention, 8. 70 days after intervention
Method of measurement
Validated Yale Brown Obsessive Compulsive Disorder Scale
Secondary outcomes
1
Description
Alteration in Neuro-Cognitive Functioning
Timepoint
In the Beginning of Study and then after Study Completion
Method of measurement
the Cambridge Neuropsychological Test Automated Battery (CANTAB)
2
Description
Assessment of Functional Reorganization of Large Scale Brain Networks
Timepoint
Before the beginning of the clinical trial and immediately after the end of that
Method of measurement
Functional Magnetic Resonance Imaging
3
Description
Expression of Na-K-Cl Co transporter (NKCC1) in Lymphocytes of the Peripheral Blood
Timepoint
Before the Beginning of the Clinical Trial and Immediately after that
Method of measurement
Real Time Polymerase Chain Reaction (RT-PCR) and Western Analysis
4
Description
Expression of K-Cl Co transporter in lymphocyte of the peripheral blood
Timepoint
Before the beginning of the Clinical Trial and Immediately after that
Method of measurement
Real Time Polymerase Chain Reaction (RT-PCR) and Western Analysis
Intervention groups
1
Description
Resistant Patient Group that receive Bumetanide in addition to the background Serotonin Reuptake Inhibitors (SRIs). Bumetanide, 3-butylamino-4-phenoxy-5-sulfamoylbenzoic acid, which is a chemical compound that inhibits Na-K-Cl-Co transporter, will be added to the background medications in two phases including: titration, steady state and then will be tapered down. This Therapeutic protocol will be started by 1 milligram daily oral dose and then will be increased to 2 milligrams daily based on patient response and adverse effects profile
Category
Treatment - Drugs
2
Description
Resistant Patient Group that Receive the standard treatment (Antipsychotics) in addition to the background Serotonin Reuptake Inhibitors (SRIs). Generally, the next standard treatment line in these patients is using low-dose second generation antipsychotics. The most common prescribed ones are risperidon and olanzapine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Mahmoudreza Hadjighassem, Mohammad Arbabi
Street address
South Kargar Street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
hosp_roozbeh@tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Sixth Floor, Central Organization of Tehran University of Medical Science, Qods Street
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8889 3978
Email
tums_edu@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Hadjighassem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Fax
+98 21 8899 1117
Email
mhadjighassem@tums.ac.ir
Web page address
http://satim.tums.ac.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Hadjighassem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Fax
+98 21 8899 1117
Email
mhadjighassem@tums.ac.ir
Web page address
http://satim.tums.ac.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Shafaghi
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 02143052000 , +98 02188991102
Email
lshafaghi@razi.tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information of the main (primary outcome) and the secondary outcomes like gene expression changes and neuronal networks reorganization outcome can be shared.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Research data will be available for the researchers of universities and scientific institutes and also relevant investigators of the industries.
Under which criteria data/document could be used
The data will be available, when the samples are taken out, all the stages of the project are completed and finalized, and the results are published.
From where data/document is obtainable
1. Dr Mahmoudreza Hdjighassem
First Address: Neuroscience Group, Reihaneh Department, Keshavarz BLVD, Imam Khomeini Hospital Complex. Tehran.
Second Address: 87, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran.
Cell Phone Number: 09126779102
Faculty Phone Number: 02143052000
Fax Number: 02188991117
Email Address: mhadjighassem@tums.ac.ir
2. Lida Shafaghi
Address: 87, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran.
Cell Phone Number: 09123832340
Fcaulty Number: 0214305200
Email Address: Lidashafaghi@gmail.com
What processes are involved for a request to access data/document
In order to receive the information, firstly the applicants send the formal application to the correspondent of the present proposal, Dr. Hadjighassem (Dean of the Department of Neuroscience and Addiction studies, School of Advanced Technologies in Medicine) and then they will be informed of the details of the data reception (including timing-that will be tried to be within the shortest possible interval- and the way of the addressing the available data like email or in person.