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

April 5, 2011 updated by: Assaf-Harofeh Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ADHD according to DSM-IV Criteria
  • Positive ASRS questionnaire

Exclusion Criteria:

  • Brain damage
  • Brain encephalopathy
  • Borderline IQ
  • Affective disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylphenidate
Device: One-night polysomnographic recordings
One-night polysomnographic recordings before and during methylphenidate treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
polysomnographic parameters
Time Frame: one- night (day 1)
one- night (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep questionnaire
Time Frame: one week
mini sleep questionnaire
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Attention Deficit Hyperactivity Disorder

Clinical Trials on One-night polysomnographic recordings

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe