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

This study has been completed.

Sponsor:

Information provided by:

Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT01329510

First received: September 1, 2010

Last updated: April 5, 2011

Last verified: August 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2010

Last Updated Date

April 5, 2011

Start Date ^ICMJE

August 2005

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

polysomnographic parameters [ Time Frame: one- night (day 1) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

sleep questionnaire [ Time Frame: one week ] [ Designated as safety issue: No ]

mini sleep questionnaire

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Device: One-night polysomnographic recordings

One-night polysomnographic recordings before and during methylphenidate treatment.

Study Arm (s)

Experimental: methylphenidate

Intervention: Device: One-night polysomnographic recordings

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ADHD according to DSM-IV Criteria
Positive ASRS questionnaire

Exclusion Criteria:

Brain damage
Brain encephalopathy
Borderline IQ
Affective disorder

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01329510

Other Study ID Numbers ^ICMJE

106/05

Has Data Monitoring Committee

Responsible Party

Dr. Shpirer Itzhak, Sleep & Snoring Clinic, Assaf Harofeh Medical Center

Study Sponsor ^ICMJE

Assaf-Harofeh Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Michael Khaigrekht, MD	Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Study Director:	Ran Shorer, M.A.	Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
Study Director:	Martin Rabey, MD	Neurology Department , Assaf Harofeh Medical Center
Principal Investigator:	Itzhak Shpirer, MD	Sleep And Snoring Clinic, Assaf Harofeh Medical Center
Study Director:	Shoky Shavit, M.A	Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center

Information Provided By

Assaf-Harofeh Medical Center

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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