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Comparison of sleep disorders in adult Attention deficit hyperactivity disorder patients treated with immediate-release methylphenidate and modified-release methylphenidate

Protocol summary

Study aim
Comparison of sleep quality of ADHD patient after continuous release of methylphenidate with rapid release of methylphenidate
Design
Randomized clinical trial, self-control of each individual, with cross-over design, non-blind, on 30 patients, randomization with toolbox software, and followed for 2 month
Settings and conduct
People over the age of 18 who have been diagnosed with ADHD based on a DSM-V by psychiatric clinical interview at Roozbeh Psychiatric Hospital and also confirmed a ADHD diagnosis by a semi-structured DIVA clinical interview conducted by a trained psychologist. Have been nominated for methylphenidate,
Participants/Inclusion and exclusion criteria
adult Patients diagnosis attention deficit hyperactivity disorder start treatment with methylphenidate Exclusion criteria: Taking any stimulant in the past month Drug abuse Taking sleeping pills Major psychiatric disorders Severe hypertension, heart failure, arrhythmia, hyperthyroidism and thyrotoxicosis, myocardial infarction and angina, glaucoma History of tics and Toure syndrome Existence of neurological diseases that accompany sleep disorders Serious side effects of methylphenidate Patient dissatisfaction with entering or continuing the study
Intervention groups
Intervention group 1: Intervention group 1: For 4 weeks, they will be treated with methylphenidate with rapid release made by Pursina company and then for 1 week without drug and then treated with continuous release drug form made by Sandoz company. Intervention group 2: They will be treated for 4 weeks with continuous release methylphenidate made by Sandoz company and then for 1 week without medicine and then treated with a quick release drug form made by Pursina company.
Main outcome variables
Anxiety, daily activity, duration and quality of sleep at the beginning and end of each period with the Pittsburgh Questionnaire ; Epworth Sleepiness Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201101049214N1
Registration date: 2021-01-27, 1399/11/08
Registration timing: registered_while_recruiting

Last update: 2021-01-27, 1399/11/08
Update count: 0
Registration date
2021-01-27, 1399/11/08
Registrant information
Name
masoud esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8065
Email address
masoudsfhn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sleep disorders in adult Attention deficit hyperactivity disorder patients treated with immediate-release methylphenidate and modified-release methylphenidate
Public title
effect of modified-release methylphenidate in sleep
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
adult Patients diagnosis attention deficit hyperactivity disorder start treatment with methylphenidate
Exclusion criteria:
History of taking any stimulant in the past month Drug abuse Taking sleeping pills such as benzodiazepines or zolpidem Major psychiatric disorders such as bipolar disorder, psychotic disorders, autism and major depression Severe hypertension, heart failure, arrhythmia, hyperthyroidism and thyrotoxicosis, myocardial infarction and angina, glaucoma History of tics and Toure syndrome Existence of neurological diseases that accompany sleep disorders such as epilepsy, vascular disorders, history of stroke, movement and Parkinson's disorders, dementia and cognitive disorders Serious side effects of methylphenidate such as seizures Patient dissatisfaction with entering or continuing the study
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
e Pittsburgh Sleep Quality Index (PSQI) , Epworth Sleepiness Scale
Randomization (investigator's opinion)
Randomized
Randomization description
Random Generator using results from random number generation software such as "Toolbox" application
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences
Street address
No. 41, Farz Mahdi Alley, Modares Ave
City
qazvin
Province
Qazvin
Postal code
3413859478
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.TUMS.TIPS.REC.1399.155

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

2

Description of health condition studied
sleep disorders
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition

Primary outcomes

1

Description
. Anxiety, daily activity, duration and quality of sleep at the beginning and end of each period with the Pittsburgh Questionnaire
Timepoint
At the beginning of the study and at 4 and 8 weeks of treatment
Method of measurement
Face-to-face interview with the patient

2

Description
Epworth Sleepiness Scale
Timepoint
At the beginning of the study and at 4 and 8 weeks of treatment
Method of measurement
Face-to-face interview with the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Intervention group 1: For 4 weeks, they will be treated with methylphenidate with rapid release made by Pursina company and then for 1 week without drug and then treated with continuous release drug form made by Sandoz company.
Category
Treatment - Drugs

2

Description
Intervention group 2: They will be treated for 4 weeks with continuous release methylphenidate made by Sandoz company and then for 1 week without medicine and then treated with a quick release drug form made by Pursina company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Psychiatry Hospital
Full name of responsible person
Masoud Esfahani
Street address
No. 41, Farz Mahdi Alley, Modares Ave
City
qazvin
Province
Qazvin
Postal code
3413859478
Phone
+98 28 3332 8056
Fax
Email
masoudsfhn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
MOHAMMAD ALI SAHRAIAN
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization,corner of Quds Street, ,Keshavarz Boulevard,
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Web page address
https://rmo.tums.ac.ir/main
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
Masoud Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 41, farz mahdi, modares Ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413859478
Phone
+98 28 3332 8065
Fax
Email
masoudsfhn@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 41, farz mahdi, modares Ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413859478
Phone
+98 28 3332 8065
Fax
Email
masoudsfhn@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 41, farz mahdi, modares Ave, qazvin
City
Qazvin
Province
Qazvin
Postal code
3413859478
Phone
+98 28 3332 8065
Fax
Email
masoudsfhn@gmail.com

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
Changes in people's sleep scores Change sleeping and waking habits
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers in scientific and academic centers
Under which criteria data/document could be used
At the request of reputable person for scientific development of the topic Coded and raw data
From where data/document is obtainable
masoudesfahani007@yahoo.com
What processes are involved for a request to access data/document
Request in the form of a mail with the sender's details and also the reason for the need for the required data If agree, as soon as possible
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