effect of modified-release methylphenidate in sleep

Phase 4

Recruiting

• 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

• Registration Number: IRCT20201101049214N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. 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.