Comparison of Donepezil and Placebo as adjunctive therapy with Ritalin on Executive Functioning of children with Attention Deficit Hyperactivity Disorder
This study compares the effectiveness of Donepezil with placebo on improving the executive functions of children with attention deficit hyperactivity disorder (ADHD). The target population is ADHD child patients who refer to Children Psychiatric Clinic of Rozbeh Hospital. Inclusion criteria : 1. Age of six to twelve years; 2. IQ above 90. Exclusion criteria : 1. an intervening physical disorder; 2. a major psychiatric disease.
Basic assessments:
1. Semi-structured diagnostic interviews for mood disorders and schizophrenia
2. Conners parent rating scale
3. Wechsler intelligence scale
4. CANTAB computer test of executive functions
5. General clinical scale for assessing the severity of symptoms of ADHD
The primary outcome: the severity of ADHD symptoms
The secondary outcome: changes in mean scores of CANTAB test for executive functions
0.5 mg Ritalin per kg per day is given to all children. Study group receives Donepezil and the control group receives placebo. Donepezil: 2.5 mg starting dose gradually reaches to ten milligrams per night by controlling the side effects.
Double-blinded method: (1) the participants are grouped by an assistant who is unaware of the treatment profile in the control or study group. The doctor that prescribes medication and visits the patient, the patient, and his/her family are unaware of the drug type. (2) First, the arrangement of participants is determined by using random numbers table for each group. Then, based on the order of referral of children, each enters into the specified group. (3) Donepezil and placebo are produced as identical tablets in similar packages by another assistant in the pharmacy and coded with 1 and 2. The patients receive the drug based on the code.
Sample size: according to the results of previous studies, the sample size is calculated 20 for each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042027506N1
Registration date:2016-05-16, 1395/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-16, 1395/02/27
Registrant information
Name
parisa pakdel
Name of organization / entity
fellow
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9154
Email address
p-pakdel@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Science
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Donepezil and Placebo as adjunctive therapy with Ritalin on Executive Functioning of children with Attention Deficit Hyperactivity Disorder
Public title
Donepezil effect in Executive Function of Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age of six to twelve years; 2. DSM-5 criteria for a diagnosis of ADHD; 3. IQ above 90. Exclusion criteria: 1. an intervening physical disorder such as neurological disorders, a record of severe allergic reaction to Ritalin or Donepezil, record of heart disease; 2. a major psychiatric disease such as mood disorders, psychotic disorders, substance abuse.
Age
From 4 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tehran University of Medical Sciences
Street address
Central Organization of University, Ghods Ave, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR-TUMS-REC-1395-2384
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
f90-0
ICD-10 code description
Disturbance of activity and attention Attention deficit: disorder with hyperactivity hyperactivity disorder syndrome with hyperactivity Excl.: hyperkinetic disorder associated with conduct disorder
Primary outcomes
1
Description
Change in severity of symptoms of Attention Deficit Hyperactivity Disorder, according to the opinion of therapist and family.
Timepoint
weeks zero, four, and eight.
Method of measurement
Conners Parent Scale and General Clinical Assessment
Secondary outcomes
1
Description
Change in mean scores of the CANTAB computer test of executive functions (working memory, planning skills, capacity of working memory, response inhibition and impulse control, measuring argument).
Timepoint
weeks zero, four, and eight
Method of measurement
CANTAB computer test
Intervention groups
1
Description
Intervention group (1): After the initial evaluation(Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group received Donepezil.
Donepezil is among the acetylcholinesterase inhibitors. In this study, Donepezil tablet manufactured by Pfizer Germany Aricept commercial name has been used and is administered orally.
Dosage
Week Zero: studies have shown that 2.5 mg is easily tolerated, so the dose starts of 2.5 mg at night and will be raised to 5 mg after 2 weeks. After two weeks, digestive problems and irritable or other complications are asked through a phone call to family. If no report of side effects was given, the dose remains constant until the end of week 4. Week 4: patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, then the CANTAB test is administered.
After assessments, Ritalin will continue with the previous dosage and Donepezil will reach 7.5 mg by week 6. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. If no report of side effects was given, a dose of 10 mg is administered in weeks 7 and 8.
Week 8: Patients refer in person. Drug side effects questionnaire and the Conners Parent Scale and General Clinical Assessment are filled and then CANTAB test is run.
Category
Treatment - Drugs
2
Description
The intervention group (2): After the initial evaluation (Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group receive placebo.
The content of placebo is Starch. Placebo pills in identical shape and size in the same package with Donepezil are prepared.
At the end of week two, digestive problems and irritation or other complications are asked through a phone call to family. At week 4 patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. At week 8: patients refer in person. First, drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rozbeh Hospital
Full name of responsible person
Parisa Pakdel
Street address
Not far from the Qazvin Square, Sought Kargar Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Yonesian
Street address
Central Organization of University, Ghods Ave, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Parisa Pakdel
Position
Fellow and Collaborative
Other areas of specialty/work
Street address
Rozbeh Hospital, not far from the Qazvin Square, Sought Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 5541 9154
Fax
Email
p-pakdel@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Univercity of Medical Sciences
Full name of responsible person
Zahra Shahrivar
Position
Associate Professor.Fellowship
Other areas of specialty/work
Street address
Rozbeh Hospital. not far from the Gazvin Square. Sought Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 5540 9495
Fax
Email
sharivar@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Parisa Pakdel
Position
Fellow
Other areas of specialty/work
Street address
Rozbeh Hospital. not far from the Square of Qazvin, Sought Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 5541 9154
Fax
Email
p-pakdel@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)