The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of tipetidine would improve psychopathology in subjects with ADHD treated with Ritaline
Design
randomized, double-blind, placebo controlled study
Settings and conduct
The study will be conducted among patients attending Roozbeh Hospital-Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of ADHD based on DSM-5; age between 6-17 years old.
Exclusion criteria: Intellectual disability; presence of any psychiatric disorders except for ODD; receiving any neuroleptic during the last 6 months, history of allergy to tipetidine or Ritaline; presence of any medical problem including cardiovascular diseases; presence of uncontrolled seizures; systolic blood pressure more than 120 mm Hg; resting pulse rate less than 60/minute or more than 115/minute
Intervention groups
Ritaline 10 to 30 mg per day and placebo as control group for 8 weeks
Ritaline10 to 30 mg per day and tipetidine 30 mg per day as inervention group for 8 weeks
Main outcome variables
Severity of ADHD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N108
Registration date:2018-04-06, 1397/01/17
Registration timing:prospective
Last update:2018-04-06, 1397/01/17
Update count:0
Registration date
2018-04-06, 1397/01/17
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tipeptidine as adjuvant therapy in children with ADHD: A double blind and randomised trial
Public title
Tipeptidine as adjuvant therapy in children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD based on DSM-5
Age between 6-17 years old
Exclusion criteria:
Intellectual disability
Presence of any psychiatric disorders except for ODD
Receiving any neuroleptic during the last 6 months
Weight less than 13.5 kg
History of allergy to Tipeptidine or Ritaline
Presence of any neurologic disease and any condition requiring surgery
Uncontrolled seizures
Systolic blood pressure more than 125 mm Hg; resting pulse rate less than 60/minute or more than 115/minute
Severe medical disease
Receiving any medication or supplement for treatment ADHD
Age
From 6 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks ( each block has four cases)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome evaluators will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4676
Health conditions studied
1
Description of health condition studied
Disturbance of activity and attention
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Severity of ADHD
Timepoint
Week 0 (before treatment) and Weeks 4 and 8 after treatment
Method of measurement
Teacher and Parent ADHD Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Ritaline 10 to 30 mg per day and placebo as control group for 8 weeks
Category
Placebo
2
Description
Intervention group: Ritaline 10 to 30 mg per day and tipetidine 30 mg per day as intervention group for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Keshvarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
Msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 912 171 1045
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be distributed through final report
When the data will become available and for how long
from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
by E mail
From where data/document is obtainable
prof Shahin Akhondzadeh
What processes are involved for a request to access data/document