Effectiveness of cannabidiol on the symptoms of patients with obsessive-compulsive disorder
Design
The clinical trial has control and intervention groups and it is a two-way blind and randomized block method.
Settings and conduct
A total of 40 patients referred to the psychiatric clinic of 22 Bahman Hospital in Qazvin are divided into two groups of intervention and control using the balance block method (Balance block randomization). Patients are asked to complete the Yale-Brown Questionnaire (YBOCS) before entering the study. intervention group received 25 mg of cannabidiol drops daily in addition to standard treatment and thecontrol groupreceived 25 mg of placebo in addition to standard treatment. Then, at weeks 4 and 8, patients are again asked to complete the Yale Brown Questionnaire to assess changes in the course of the disease.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age more than 18 years and less than 55 years
2. The patient's physical health
3. Diagnosis of OCD based on DSM-5 criteria
4. Obtain a minimum score of 16 in the Yale-Brown Scale Questionnaire
5. Do not take any psychiatric drugs except SSRIs during the last 4 weeks
6. No previous use of cannabis or other psychotropic drugs
Exclusion criteria:
1- Patient dissatisfaction
2- Having other psychiatric disorders, including cognitive disorders, psychotic disorders, drug use, etc.
3. Having physical disorders that increase the risk of side effects of the treatment
4. Pregnancy, desire to conceive and breastfeeding
5. Achieve a score above 17 of the Beck Depression Inventory before starting the project
Intervention groups
In the intervention group, in addition to normal treatment, patients are prescribed 25 mg of cannabidiol drops daily, and in the control group, in addition to normal treatment, to patients placebo will be prescribed.
Main outcome variables
Obsessive-Compulsive Scale
General information
Reason for update
Acronym
OCD
IRCT registration information
IRCT registration number:IRCT20210310050660N1
Registration date:2021-04-01, 1400/01/12
Registration timing:prospective
Last update:2021-04-01, 1400/01/12
Update count:0
Registration date
2021-04-01, 1400/01/12
Registrant information
Name
Mahnaz Majidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5054
Email address
m.majidi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Cannabidiol effect as adjunctive therapy on symptoms of patients with Obsessive-Compulsive Disorder
Public title
Evaluation of Cannabidiol effect in treatment of patients with Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being healthy
Obssesive compulsive disorder (OCD) diagnosis through DSM-5 criteria ( DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS, 5TH EDITION)
Achieving at least score 16 according to YALE BROWN OBSSESIVE COMPLUSIVE SCORE ( YBOS)
Being only on SSRIs through recent 4 weeks
Do not have history of using cannabis or other ilicit drugs
Exclusion criteria:
Unwilling to participate in this study
Having history of other psychiatric disorder including psychotic, cognitive and substance use disorder
Being medically ill that cause more side effects than usual
Pregnancy, expecting to being pregnant and lactation
Achieving score more than 17 through completing Beck Depression scale before starting study
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two treatment groups A and B using the balance block method (Balance block randomization), the size of each block is 6 and the total number of blocks is 10. Balanced randomization allocation method is used for participants in a randomized controlled clinical trial study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of their treatment, and medications are given in asymptomatic packages to the clinician who is not aware of the patient's treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Deputy of research and technology, Vali-asr street
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.QUMS.REC.1399.502
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
Intensity of obsessive-compulsive disorder
Timepoint
Before entering into study, in week 4 and 8
Method of measurement
Yale–Brown Obsessive Compulsive Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard treatment, 25 mg of cannabidiol drop were administered orally daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: In addition to standard treatment, 25 mg placebo drop were administered orally for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital ,Qazvin
Full name of responsible person
Mahnaz Majidi
Street address
22 Bahman Hospital, Parstar Alley, Rah-ahan street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3369 9022
Email
Mahnaz.majidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
Deputy of Research and Technology, Vali-asr street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3335 5162
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Majidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Parstar Alley, Rah-ahan street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3369 9022
Email
Mahnaz.majidi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Majidi
Position
22 Bahman Hospital, Parstar Alley, Rah-ahan street
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Parstar Alley, Rah-ahan street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3369 9022
Email
Mahnaz.majidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Majidi
Position
Assistan Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Parstar Alley, Rah-ahan street
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3369 9022
Email
Mahnaz.majidi@yahoo.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available.
When the data will become available and for how long
Availability will be immediately after the publication of the article.
To whom data/document is available
The data will be available to everyone.
Under which criteria data/document could be used
All required analyzes can be performed and there will be no special conditions for access.
From where data/document is obtainable
For correspondence send Email to Dr. Majidi/ Mahnaz.majidi@yahoo.com
What processes are involved for a request to access data/document
It will reach the applicant in the shortest possible time.