Determining the effect of cannabidiol in improving clinical symptoms in patients with schizophrenia
Design
40 patients are randomly divided into 2 equal groups of intervention and control. The sample size is considered 20 people in each intervention and control group.
Settings and conduct
The study is designed as a randomized three-blind randomized clinical trial in which are studied 40 patients with schizophrenia hospitalized in 22 Bahman Hospital in Qazvin.
Participants/Inclusion and exclusion criteria
Patients with schizophrenia admitted to Qazvin Bahman 22 hospital.
Inclusion criteria: Diagnosis of schizophrenia based on DSM-5 criteria, Candidate for treatment only with Raspiridone as an antipsychotic, PANSS score greater than 60 on arrival, No cognitive impairment, No drug resistance;
Exclusion criteria: Patient dissatisfaction Breastfeeding and pregnancy or desire to become pregnant within 3 months after the end of the project, Consumption of stimulants and hallucinogens and cannabis, Patients with schizophrenia without positive symptoms, Candidates for ECT.
Intervention groups
Patients receive their usual treatment (atypical antipsychotics) during the study. The intervention group is given cannabidiol drop and the control group is given a placebo.
Main outcome variables
Positive symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210310050660N2
Registration date:2021-04-06, 1400/01/17
Registration timing:prospective
Last update:2021-04-06, 1400/01/17
Update count:0
Registration date
2021-04-06, 1400/01/17
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
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cannabidiol on positive symptoms in schizophrenic patients
Public title
Evaluation of the effect of cannabidiol in the treatment of schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM–5) criteria
Hospitalized in 22 Bahman Hospital in Qazvin
Candidate for treatment only with rispidone as an antipsychotic
Patient and legal guardian willingness to enter the study
Positive and Negative Syndrome Scale (PANSS) score over 60 When entering the study
Absence of cognitive disorders
Lack of drug resistance
Exclusion criteria:
Breastfeeding and pregnancy or desire to conceive within 3 months after completion of the plan.
Consumption of stimulants and hallucinogens and cannabis
Patients with schizophrenia without positive symptoms
candidate for Electroconvulsive Therapy (ECT)
Age
No age limit
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
In this method was used from a simple randomization model of random number table and we place each participant in the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs including cannabidiol and placebo drops, with the same shape and taste, were packaged with a label of herbarium at Alborz Pharmaceutical Company.
The treating physician, researcher, and statistical analytics consulting who were all different people did not know any of the coding and content of each code; Therefore, this study was considered three-blind.
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
Street address
Dept of research Qazvin University of Medical Sciences, Valiasr Avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.QUMS.REC.1399.504
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive symptoms
Timepoint
At the beginning of the study (before the intervention) and 2, 4 and 6 weeks after the start of treatment
Method of measurement
PANSS Questionnaire Scores (Anderson Test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty patients with schizophrenia were treated with the common drug and cannabidiol drop. Patients received their present treatment (atypical antipsychotic risperidone) during the study and were matched in terms of dosage and type of antipsychotic drug. The intervention group was given cannabidiol drop (150 mg daily) for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: Twenty patients with schizophrenia were treated with common drug and placebo drops. Patients received risperidone during their usual course of treatment (atypical antipsychotic risperidone) and were matched in terms of dosage and type of antipsychotic drug. The control group was given placebo drops (150 mg daily) for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22-Bahman hospital
Full name of responsible person
Mohammad Mahdi Emam Jome
Street address
Dept of research Qazvin University of Medical Sciences, Valiasr Avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 7006
Email
m_emamjomeh@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
Dept of research Qazvin University of Medical Sciences, Valiasr Avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 7006
Email
m_emamjomeh@yahoo.com
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, Rah-ahan avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3355 5054
Email
m.majidi@qums.ac.ir
Person responsible for scientific 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, Rah-ahan avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3355 5054
Email
m.majidi@qums.ac.ir
Person responsible for updating data
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, Rah-ahan avenue
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3355 5054
Email
m.majida@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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