Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation
|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.|
|ClinicalTrials.gov Identifier: NCT00065286|
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : June 24, 2005
|Condition or disease|
Akathisia is a relatively common side effect of neuroleptic medication that occurs within 1 week to 6 months after the initiation of medication. Akathisia is characterized by a variety of movement manifestations, such as fidgeting, irritability, inability to sit or stand still, marching in place, continuous trunk motions, sleeplessness, and a subjective sense of restlessness. Akathisia has been studied primarily in schizophrenic patients, although reports on individuals with mental retardation suggest that akathisia also occurs in this population. This study will characterize the movement dynamics of akathisia in schizophrenic and mentally retarded adults using two experimental series.
The first experimental series will compare chronic akathisia in schizophrenic and MR patients. Four groups of MR patients and four groups of schizophrenic patients will be studied: young (age 18 to 38) with chronic akathisia, older (age 40 to 60) with chronic akathisia, young on neuroleptics without akathisia, and older on neuroleptics without akathisia. Two control groups will include healthy individuals with normal intelligence who are not on neuroleptic medication. Assessments will include videotaped recordings and kinematic analysis of naturally occurring akathisia restlessness movements as well as cognitive and psychiatric tests. Demographic factors (age and sex) and medication factors (type and duration) will also be assessed to determine their relation to and possible impact on chronic akathisia.
The second experimental series will compare schizophrenic and MR patients who are initiating neuroleptic therapy. Institutionalized MR patients will be age matched with schizophrenic patients. Tests will occur at baseline (prior to drug initiation) and at Weeks 1, 2, 4, 8, 16, 24, and 52. Those who enroll in the protocol early will be tested for more than 12 months where possible and useful. The same analyses as in the first experimental series will be used to allow for comparison of acute and chronic akathisia.
|Study Type :||Observational|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Movement Dynamic Analyses of Akathisia|
|Study Start Date :||December 1996|
|Study Completion Date :||November 1999|
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): NCT00065286
|United States, North Carolina|
|Western Carolina Center|
|Morganton, North Carolina, United States, 28655|
|United States, Pennsylvania|
|Department of Kinesiology|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Karl M Newell, Ph. D.||Department of Kinesiology|