Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

— ADHD  

Official title:

The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329510
• Other study ID #: 106/05
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: April 5, 2011
• Start date: August 2005
• Est. completion date: May 2007

Study information

• Verified date: August 2005
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Description:

Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have described the effect of stimulants on sleep patterns. However the data on adults with ADHD is sparse.

The aim of this study is to investigate the effects of methylphenidate on sleep in adults with ADHD using polysomnographic parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ADHD according to DSM-IV Criteria

• Positive ASRS questionnaire

Exclusion Criteria:

• Brain damage

• Brain encephalopathy

• Borderline IQ

• Affective disorder

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• One-night polysomnographic recordings
One-night polysomnographic recordings before and during methylphenidate treatment.

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polysomnographic parameters		one- night (day 1)	Yes
Secondary	sleep questionnaire	mini sleep questionnaire	one week	No