Comparison of the effectiveness of risperidone and aripiprazole in reducing aggression in hospitalized adolescents with conduct disorder
Design
A double-blind phase 2 randomized clinical trial on 62 patients
Settings and conduct
Razi Psychiatric hospital, pediatric ward. Patients and researchers do not know the type of medicine.
Participants/Inclusion and exclusion criteria
Age 10-18 years old, conduct disorder, patients admitted to the pediatric psychiatric ward, no bipolar or psychotic disorder, no suicidal idea
Intervention groups
Intervention group 1: Treatment with 1 mg risperidone. Intervention group 2: treatment with 2.5 mg aripiprazole.
Main outcome variables
Aggression; side effects of medications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210718051932N1
Registration date:2021-07-25, 1400/05/03
Registration timing:prospective
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Abbas MAHMOUDI GHARA
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 7263
Email address
af2mahmoudi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-31, 1400/05/09
Expected recruitment end date
2021-09-09, 1400/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of risperidone and aripiprazole in controlling aggression in inpatient adolescents with conduct disorder
Public title
Comparison of the effectiveness of risperidone and aripiprazole in controlling aggression in inpatient adolescents with conduct disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conduct disorder by criteria DSM5
Age 10-12 years old
Patient admitted to the psychiatric ward
Exclusion criteria:
Bipolar disorder
Suicidal idea
Psychotic disorder
Drug allergy to risperidon or aripiprazol
Severe medical problems
Age
From 10 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way and by card. The type of intervention is written on the card and is placed in sealed envelopes. According to the sample size, 62 people of both sexes, 32 people in each group, are placed in the list of participants according to the referral order. After entering the study, each person is asked to choose an envelope. According to the predicted sample size, the envelopes are prepared (without replacement).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug (intervention 1 or intervention 2) in enclosed sealed envelopes. The coding is done by one of the project partners and the doctor, evaluator and patient are blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Rehabilitation Sciences and Social Health
Street address
unit 6, No 32, 4th Ave, Mozhdeh Blvd, Hosinabad, Tehran
City
Tehran
Province
Tehran
Postal code
1668847177
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.USWR.REC.1400.116
Health conditions studied
1
Description of health condition studied
Conduct disorder
ICD-10 code
F91
ICD-10 code description
Conduct disorders
Primary outcomes
1
Description
Aggression
Timepoint
At the end of 1, 2, 4, 6 weeks,
Method of measurement
Bass and Perry Clinical Global Impression scale (CGI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group starts treatment with a dose of 1 mg of risperidone and then gradually increases the dose of risperidone to 4 mg due to patient tolerance and no drug side effects over 6 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: The other group is treated with 2.5 mg of Aripiperazole and then gradually according to the patient's tolerance and over 6 weeks, the drug dose of group 2 is increased and the dose of Aripiprazole drug is increased to 20 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Nastaran Habibi
Street address
Amin Abad , RaziPsychiatric Hospital
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1220
Fax
+98 21 3340 1600
Email
dr_nhabibi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza khankeh
Street address
Kodakyar ave, Daneshjo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1777234562
Phone
+98 21 2218 0083
Email
Hamid.khankeh@ki.se
Web page address
https://rehabnursing.uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Abbas Mahmoudi Ghara
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
32,4 Ave, Mozhdeh Blvd, Hoseinabad sqare
City
Tehran
Province
Tehran
Postal code
1668847177
Phone
+98 21 2297 7263
Email
af2mahmoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nastaran Habibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Kodakyar ave ,Velanjak, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1772356872
Phone
+98 21 2218 0083
Email
dr_nhabibi@yahoo.com
Web page address
https://rehabnursing.uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Abbas Mahmoudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
32 acssesory, 4th Ave, Mozhdeh street, Hoseinabad square, Tehran
City
Tehran
Province
Tehran
Postal code
1668847177
Phone
+98 21 2297 7263
Email
af2mahmoudi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available