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effect of modified-release methylphenidate in sleep

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201101049214N1
Enrollment
30
Registered
2021-01-27
Start date
2020-11-21
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Attention deficit hyperactivity disorder. Condition 2: sleep disorders. Attention-deficit hyperactivity disorders Sleep disorders not due to a substance or known physiological condition

Interventions

Intervention 1: 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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: adult Patients diagnosis attention deficit hyperactivity disorder start treatment with methylphenidate

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
. 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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Esfahani

Tehran University of Medical Sciences

masoudsfhn@gmail.com+98 28 3332 8065

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026