The effect of dextromethorphan on the severity of symptoms and brain function in patients with obsessive-compulsive disorder, a study using event-dependent potentials (ERP)
Design
A randomized clinical trial, on 50 patients (two groups of 25 people), block randomization (via randomization site), parallel groups, double-blind, phase 3
Settings and conduct
This is a randomized Triple-blind study.This study will be performed on 50 patients with obsessive-compulsive disorder, who will be referred to outpatient clinical of EbneSina Hospital. Patients will be evaluated separately by a psychiatrist. The severity of obsessive-compulsive disorder in these patients will be assessed at the beginning of the study by interviewing a psychiatrist using the Yale Brown Obsessive-Compulsive Disorder (Y-BOCS) scale , who meet the inclusion and exclusion criteria, will enter the study after obtaining informed consent.The results of the psychiatrist's interview with the patient and the evaluation of (Y-BOCS) scale will be recorded in a special questionnaire for each patient at the beginning of the study (before the intervention) and 1 month, 2 months and 3 months after the intervention.
Participants/Inclusion and exclusion criteria
1)OCD patients who have been treated with high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 15. (High doses of SSRI includ: Sertraline 200mg/day, Paroxetine 60mg/day, Fluoxetine 80mg/day and Fluvoxamine mg/day) 2)subjects aged 18 to 60 years 3) Obtaining the patient's informed consent
Intervention groups
group1: high dose of SSRI + placebo group.group2: high dose of SSRI + dextromethorphan (60 mg/day)
Main outcome variables
(Y-BOCS) YALE-BROWN OBSESSIVE COMPULSIVE SCALE
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013359N6
Registration date:2022-04-20, 1401/01/31
Registration timing:registered_while_recruiting
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Seyed Alireza Sadjadi
Name of organization / entity
Mashhad University Of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1711 2721
Email address
sadjadia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dextromethorphan on the severity of symptoms and brain function in patients with obsessive-compulsive disorder: An ERP study
Public title
The effect of dextromethorphan on the severity of symptoms and brain function in patients with obsessive-compulsive disorder: An ERP study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with obsessive-compulsive disorder who have been treated with high doses of SSRI for at least 8 weeks but whose Y-BOCS index is higher than cut-off 15.People aged 18 to 60 yearsObtain patient informed consent
People aged 18 to 60 years
Obtain patient informed consent
Exclusion criteria:
Pregnancy or breastfeeding
Using serotonergic drugs other than SSRIs
Use of NMDA receptor antagonists other than memantine and dextromethorphan
Major Depressive Disorder (Based on DSM-IV-TR Criteria)
Psychotic and bipolar disorders (based on DSM-5 criteria)
Other anxiety disorders (such as panic disorder, post-traumatic stress disorder (PTSD), general anxiety disorder (GAD)
Abuse or dependence on drugs or alcohol
Liver dysfunction (LFT> 3ULN)
Kidney dysfunction (GFR <60 ml / kg / min)
Thyroid Disorders (Based on Thyroid Function Test)
History of seizures
Cognitive-behavioral therapy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is done using the site https://www.sealedenvelope.com.
Each block has 8 members and for example can be as follows:
[AABBCCDD], [ABCDABCD], [AABBDCD],…
Codes A, B, C, D are assigned randomly to the intervention groups and the control group. The aforementioned site randomly selects 9 blocks from all eight-member blocks so that 50 patients can be included in the study.The allocation concealment method is by use of opaque sealed envelopes with random sequences obtained from the random allocation step.
Blinding (investigator's opinion)
Double blinded
Blinding description
As our data are collected step by step and patients are gradually included in the study, concerning the time of inclusion and at the beginning of inclusion according to the sequence obtained in the randomization stage, the patients will be assigned to either control groups or interventions groups. These codes are provided to the researcher present in the physician's office. It is worth mentioning that this researcher should be fully aware of the type of code. The researcher is also provided with the medications in terms of the assigned number (D or C or B or A) and is fully aware of the fact that which medication is Memantine or placebo, as well. (This researcher is engaged neither in prescribing and evaluating the treatments, nor in analyzing data, and is exclusively responsible for maintaining codes and delivering medications to the patients based on a random code allocated by the physician.) The assigned code is recorded in the CRF form.
Initially, the prepared codes are given to the researcher, if the inclusion criteria are fulfilled and based on the codes, the patient is randomly included in one group. The allocated code is documented in the CRF form and the researcher takes the drugs or placebo into account based on the code assigned to the patient. After taking either the medication or placebo for three months by the patients, in the clinic of Ebn-e-Sina Hospital, the patients are appraised by a physician who has no idea which drug the patients have received and is only aware of the assigned codes and then carries out the appropriate evaluations. After documentation, the results in the form of codes are provided to the person who performs the data analysis. The data analysis is performed while the data analyzer has no information about the type of the taken medication, and all confidential information is recorded and stored without mentioning the patient's name
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.547
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
Changing of the latency and amplitude of brainwave components in the ERP study.
Timepoint
Before intervention and 1 month, 2 months and 3 months after intervention.
Method of measurement
Yale–Brown Obsessive Compulsive Scale
Secondary outcomes
1
Description
Changes in quantitative electroencephalography (QEEG)
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Quantitative Electroencephalogram
Intervention groups
1
Description
Intervention group: Patients are selected from outpatients who visit the clinic of EbneSina Hospital. In the intervention group, patients diagnosed with obsessive-compulsive disorder, who meet the inclusion and exclusion criteria, will randomly add one of the following four interventions to their high-dose (SSRI) regimen. (This study will be performed on patients with obsessive-compulsive disorder who have been on high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 15) The severity of symptoms of obsessive-compulsive disorder will be assessed using the Yale Brown Obsessive-Compulsive Disorder Scale before intervention and 1 month, 2 months and 3 months after intervention. Quantitative electroencephalography (QEEG) will be done before the intervention and 3 months after the intervention. Intervention group1: high dose of SSRI (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) + dextromethorphan (60 mg/day). The main medication, dextromethorphan, is purchased from Sobhan pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: high dose of SSRI + placebo The placebo tablet contains all the ingredients of the main pill and only lacks the active ingredient Memantine, and will receive 4 tablets a day for 3 months in addition to the standard treatment regimen for obsessive-compulsive patients. The placebo tablet, which is similar to the main medication in terms of shape and color is made in Mashhad School of Pharmacy in accordance with the principles of GLP.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn'e Sina Hospital, Outpatient Clinic
Full name of responsible person
Alireza Sadjadi
Street address
BuAli square, Horr Ameli Boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1592
Email
sadjadia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghayour Mobarhan Majid
Street address
Daneshgah street, Ghoreyshi bulding
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sadjadi Alireza
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
BuAli square, Horr Ameli Boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3711 2701
Email
sadjadia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadjadi Alireza
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
BuAli square, Horr Ameli Boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3711 2701
Email
sadjadia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadjadi Alireza
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
BuAli square, Horr Ameli Boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3711 2701
Email
sadjadia@mums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
only available for people working in academic institutions and there is not another condition
From where data/document is obtainable
sadjadia@mums.ac.ir
What processes are involved for a request to access data/document