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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
  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: 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:

U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • sleep questionnaire [ Time Frame: one week ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 1, 2010
Last Updated: April 5, 2011
Health Authority: Israel: Ministry of Health

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013