- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945031
The Study of Pharmacological Treatment Pattern for Cannabis-induced Psychosis
June 21, 2021 updated by: Mahidol University
A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand.
All patients who admitted at PMNIDAT from October 2013 to September 2019 were included.
Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included.
Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety.
Antipsychotic drug was still a key psychotropic drugs for treatment of CIP.
However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics
Study Overview
Study Type
Observational
Enrollment (Actual)
317
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pathum Thani
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Thanyaburi, Pathum Thani, Thailand, 12110
- Onrumpha Chuenchom
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Medical chart which diagnosis by ICD-10 with cannabis-induced psychosis who admitted at PMNIDAT from October 2013 to September 2019 at Princess Mother National Institute on Drug Abuse Treatment.
Description
Inclusion Criteria:
- Patients ≥ 12 years of age
- Patients who had been diagnosed as Cannabis-induced psychosis by International statistical Classification of Disease and Related Health problem (ICD-10) on 2016 code F12.5
- Patients had history of use of cannabis in medical chart
- Patients had the positive urine screening test of cannabis at the first day of admission
Exclusion Criteria:
- Patients had psychosis from organic psychosis, defined by diagnosis by ICD-10 code F09.6
- Unavailable data for evaluate of outcome especially data of drug use, content of drug use or urine screening test
- Patients who cancel of medical treatment before 7 day after admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cannabis-induced psychosis
|
This study is observational study, we recorded history of substance used, symptoms and medication in a medical chart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacological treatment pattern for cannabis-induced psychosis
Time Frame: 30 days
|
Pharmacological treatment pattern for cannabis-induced psychosis during admission
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Brief psychiatric rating scale (BPRS) form the first day of admission
Time Frame: Day1, Day 8, Day 15 and Day 22
|
A high BPRS score is more severe of symptoms than a lower score
|
Day1, Day 8, Day 15 and Day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2019
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (Actual)
June 30, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-DT/PY-IRB2019/PY114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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