Evaluation and Comparison of the Effect of Haloperidol, Risperidone, and Quetiapine Medications in the Treatment of Delirium in End-stage Cancer Patients
Determining the Effect of Haloperidol, Risperidone, and Quetiapine in the Treatment of Delirium in End-stage Cancer Patients
Design
This study is a clinical trial with a control group, with parallel groups and randomly controlled double-blind, phase 3 on 60 patients, which examines and compares the effects of haloperidol, quetiapine, and risperidone. The random block method is used for randomization.
Settings and conduct
The study sample is selected from patients of Omid Hospital. Medications are started at the lowest dose and increased daily until the delirium symptoms improve or the dose is reached. The Intensive Care Delirium Screening Checklist is used to assess the response to treatment. This questionnaire is completed daily until recovery and then every 2-7 days after recovery. One person randomizes individuals into three groups and then adjusts the daily dose of the drug until a therapeutic response is achieved. The second person, who has no information about the type of drug used, evaluates patients on a daily basis using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of any type of end-stage cancer, informed consent of the patient or family, age over 18 years, diagnosis of delirium based on DSM-V criteria; Exclusion criteria: Existence of major neuromagnetic disorder, prohibition of antipsychotic drugs
Intervention groups
Group 1: Haloperidol Receiver (1-6 mg daily)
Group 2: Quetiapine Receiver (25-400mg daily)
Group 3: Risperidone Receiver (1-6 mg daily)
Main outcome variables
Delirium score based on the Intensive Care Delirium Screening Checklist
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190404043159N3
Registration date:2021-04-02, 1400/01/13
Registration timing:registered_while_recruiting
Last update:2021-04-02, 1400/01/13
Update count:0
Registration date
2021-04-02, 1400/01/13
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
sharbafchi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and Comparison of the Effect of Haloperidol, Risperidone, and Quetiapine Medications in the Treatment of Delirium in End-stage Cancer Patients
Public title
Evaluation of the Effect of Haloperidol, Risperidone, and Quetiapine in the Delirium of Cancer Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of any Type of End-stage Cancer
Informed Consent of the Patient or Family
More than 18 Years Old
Diagnosis o Delirium Disorder According to DSM-V Criterion
Exclusion criteria:
Presence of Major Neurocognitive Disorder
Contraindication for Consumption of Antipsychotic Medications
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Treatment methods are identified as A, B, and C. Individuals are divided into 3 groups by the random block method. In this way, the first 3 qualified people are selected and included in the study. These 3 people are considered as a triple block and are arranged according to the last digit of the national code. We identify all three compounds and decode them after the last prescription of the drugs for the last block.
Blinding (investigator's opinion)
Double blinded
Blinding description
One person randomizes individuals into three groups and then adjusts the daily dose of the drug until a therapeutic response is achieved. The second person, who has no information about the type of drug used, evaluates patients on a daily basis using a questionnaire and provides the results to the doctor who adjusts the dose of the drug based on the patient code. Patients are also unaware of the type of medication they are receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 18, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-09-11, 1399/06/21
Ethics committee reference number
IR.MUI.MED.REC.1399.482
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Malignancy
ICD-10 code
C80.1
ICD-10 code description
Malignant (primary) neoplasm, unspecified
Primary outcomes
1
Description
Delirium Score in Intensive Care Delirium Screening Checklist
Timepoint
Before the intervention and daily for up to 7 days after remission
Method of measurement
Intensive Care Delirium Screening Checklist
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Abidi's haloperidol tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached.
Category
Treatment - Drugs
2
Description
Second Intervention group: Abidi's Quetiapine tablets (25-400 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached.
Category
Treatment - Drugs
3
Description
Third Intervention group: Abidi's Risperidone tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Research, Educational, Therapeutic Complex
Full name of responsible person
Mohammad Reza Sharbafchi
Street address
Motahari Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3235 0210
Email
Omidhospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 18, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sharbafchi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 18, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sharbafchi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 18, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
sharbafchi@med.mui.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 data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.