Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation

This study has been completed.

First Received on July 21, 2003.  
Last Updated on June 23, 2005  
History of Changes
This Clinical Trial Sponsored By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00065286

Purpose for Clinical Trial

Akathisia is a movement disorder that is often a side effect of certain psychiatric drugs. People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock from foot to foot, and pace. Akathisia is sometimes called “restless legs syndrome.” The drugs that can cause akathisia are most often used to treat patients with schizophrenia or mental retardation (MR). This study will evaluate akathisia in both schizophrenic and MR patients who either have long-term akathisia or who are starting treatment with psychiatric drugs.

Condition Clinical Trial Phase
Akathisia Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Movement Dynamic Analyses of Akathisia

Resource links provided by NLM:

MedlinePlus related topics:
Restless Legs

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date: December 1996
Estimated Study Completion Date: November 1999

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria for Experimental Series I

  • Chronic akathisia for at least 3 months prior to study entry
  • Neuroleptic medication for at least 6 months prior to study entry (anticonvulsant medication will be accepted and those on carbamazepine and ethosuximide will be monitored for the development of akathisia)
  • Mental retardation/developmental delay diagnosis based on American Association of Mental Deficiency definition or diagnosis of schizophrenia based on the DSM-IV criteria

Inclusion Criteria for Control Group

  • Control groups will be matched to akathisia groups based on age and level of disability (IQ for mental retardation population, BPRS positive symptoms of schizophrenia for schizophrenic groups).

Exclusion Criteria

  • Psychotropic drugs such as serotonin re-uptake inhibiting anti-depressants
  • Nonambulatory
  • Uncontrolled seizure disorders
  • Fragile X syndrome
  • Down Syndrome
  • Neurological disease that is known to have definitive symptoms of choreoathetosis, dystonia, Syndenham’s chorea, etc.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Karl M Newell, Ph. D. Department of Kinesiology
  More Information


Newell KM, Incledon T, Bodfish JW, Sprague RL. Variability of stereotypic body-rocking in adults with mental retardation. Am J Ment Retard. 1999 May;104(3):279-88.
Newell KM, Bodfish JW, Mahorney SL, Sprague RL. Dynamics of lip dyskinesia associated with neuroleptic withdrawal. Am J Ment Retard. 2000 Jul;105(4):260-8.
Newell KM, Wszola B, Sprague RL, Mahorney SL, Bodfish JW. The changing effector pattern of tardive dyskinesia during the course of neuroleptic withdrawal. Exp Clin Psychopharmacol. 2001 Aug;9(3):262-8.
Newell KM, Ko YG, Sprague RL, Mahorney SL, Bodfish JW. Onset of dyskinesia and changes in postural task performance during the course of neuroleptic withdrawal. Am J Ment Retard. 2002 Jul;107(4):270-7.

ClinicalTrials.gov Identifier:

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