NCT01329510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
Last Updated

April 6, 2011

Status Verified

August 1, 2005

Enrollment Period

1.3 years

First QC Date

September 1, 2010

Last Update Submit

April 5, 2011

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDAdult

Outcome Measures

Primary Outcomes (1)

  • polysomnographic parameters

    one- night (day 1)

Secondary Outcomes (1)

  • sleep questionnaire

    one week

Study Arms (1)

methylphenidate

EXPERIMENTAL
Device: One-night polysomnographic recordings

Interventions

One-night polysomnographic recordingsDEVICE

One-night polysomnographic recordings before and during methylphenidate treatment.

methylphenidate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Zrifin, Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • 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

    STUDY DIRECTOR

  • Itzhak Shpirer, MD

    Sleep And Snoring Clinic, Assaf Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

  • Shoky Shavit, M.A

    Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2010

First Posted

April 6, 2011

Study Start

August 1, 2005

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

April 6, 2011

Record last verified: 2005-08

Locations

IL(1)