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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329510
First Posted: April 6, 2011
Last Update Posted: April 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Condition Intervention
Attention Deficit Hyperactivity Disorder Device: One-night polysomnographic recordings

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • polysomnographic parameters [ Time Frame: one- night (day 1) ]

Secondary Outcome Measures:
  • sleep questionnaire [ Time Frame: one week ]
    mini sleep questionnaire


Enrollment: 19
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methylphenidate Device: One-night polysomnographic recordings
One-night polysomnographic recordings before and during methylphenidate 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain damage
  • Brain encephalopathy
  • Borderline IQ
  • Affective disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329510


Locations
Israel
Assaf Harofeh Medical Center
Zrifin, Israel, 70300
Sponsors and Collaborators
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
  More Information

Responsible Party: Dr. Shpirer Itzhak, Sleep & Snoring Clinic, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01329510     History of Changes
Other Study ID Numbers: 106/05
First Submitted: September 1, 2010
First Posted: April 6, 2011
Last Update Posted: April 6, 2011
Last Verified: August 2005

Keywords provided by Assaf-Harofeh Medical Center:
ADHD
Adult

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents