Comparative study of the effectiveness of atomoxetine with Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder
Determining the effectiveness of atomoxetine in comparison with the combination of Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 100 patients
Settings and conduct
In this randomized double-blind clinical trial, 100 eligible patients referred to the neurology clinics of Khorshid Psychiatric Clinic, and Amin in Isfahan will be included in the study and will be randomly divided into two groups. Patients in the first group will be prescribed Ritalin and fluoxetine and in the second group atomoxetine. The intervention will be performed in such a way that the patient and the researcher will have no knowledge of the type of intervention and the double-blind conditions will be established. The severity of hyperactivity and anxiety in children will then be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included students aged 6 to 12 years referred to Khorshid Psychiatric Clinic, and Amin, attention deficit hyperactivity disorder, and anxiety disorder based on DSM-5 primary school age (6 to 12 years). Exclusion criteria include having any chronic illness and having a family history of psychosis and mood disorders in the first-degree family.
Intervention groups
Intervention group 1: Patients in this group are given Ritalin at a dose of 5 mg twice a day orally and an increase of 10 mg weekly. Fluoxetine also starts at a dose of 2.5-5 mg and is increased weekly.
Intervention group 2: Patients in this group start with atomoxetine at a dose of 0.5 mg per kg and increase it weekly to a dose of 1.4 mg per kg.
Main outcome variables
The severity of Anxiety; Severity of Attention, Performance score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052670N2
Registration date:2022-01-19, 1400/10/29
Registration timing:prospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of atomoxetine with Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder
Public title
The effectiveness of atomoxetine with Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder, and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students 6 to 12 years old referred to Khorshid Psychiatric Clinic, and Amin
Attention Deficit Hyperactivity Disorder and Anxiety Disorder based on DSM-5 Primary age (6 to 12 years)
Exclusion criteria:
Having any chronic illness
Family history of psychosis and mood disorder in the family first degree
Age
From 6 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 100 eligible patients are randomly selected. For this, the letter A is written on 50 sheets, the letter B is written on 50 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the drugs are prepared in the same shape before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient, the patient, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.MUI.MED.REC.1400.111
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder and Anxiety Disorders
Before the intervention, 1 and 4 months after the start of the intervention
Method of measurement
The child and parent Screen for Child Anxiety Related Emotional Disorders (SCARED)
2
Description
Severity of Attention Deficit Hyperactivity Disorder
Timepoint
Before the intervention, 1 and 4 months after the start of the intervention
Method of measurement
Conners' Continuous Performance Test
3
Description
Performance score
Timepoint
Before the intervention, 1 and 4 months after the start of the intervention
Method of measurement
The Child Anxiety Impact Scale (CAIS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group are given Ritalin at a dose of 5 mg twice a day (morning and evening) orally and an increase of 10 mg weekly (until clinical response and parental consent). Fluoxetine also starts at a dose of 2.5-5 mg and is increased weekly until it is eventually increased to a dose of 10 to 20 mg. It is given once a day, often in the morning.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group start with atomoxetine at a dose of 0.5 mg per kg and increase it weekly to a dose of 1.4 mg per kg. The medicine is given in the morning.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Afsaneh Karbasi Amel
Street address
Isfahan University of Medical Sciences and Health Services , Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
afsanehkarbasi@yahoo.com
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Afsaneh Karbasi Amel
Street address
Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۱۴۱
Phone
+98 31 3445 5051
Email
afsanehkarbasi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsaneh Karbasi Amel
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
afsanehkarbasi@yahoo.com
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
Afsaneh Karbasi Amel
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No 7, Berlian deadend , Erfani alley, Azar alley
City
Isfahan
Province
Isfehan
Postal code
8133714131
Phone
+98 31 3233 6413
Email
afsanehkarbasi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahrzad Aghili
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No 7, Berlian deadend , Erfani alley, Azar alley
City
Isfahan
Province
Isfehan
Postal code
8133714131
Phone
+98 31 3233 6413
Email
aghili.shahrzad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahrzad Aghili
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.7, Berlian deadend, Erfani alley, Azar alley
City
Isfahan
Province
Isfehan
Postal code
8133714131
Phone
+98 31 3233 6413
Email
aghili.shahrzad@yahoo.com
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