NCT00065286

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 1996

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

December 1, 1996

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

July 21, 2003

Last Update Submit

June 23, 2005

Conditions

Akathisia

Keywords

AkathisiaMental retardationSchizophreniaNeuroleptic medicationTardive dyskinesiaBrief Psychiatric Rating ScaleBarnes testStereotypy Checklist TestDISCUS Tardive Dyskinesia test

Eligibility Criteria

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

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Western Carolina Center

Morganton, North Carolina, 28655, United States

Location

Department of Kinesiology

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

  • 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. doi: 10.1352/0895-8017(1999)1042.0.CO;2.

    PMID: 10349469BACKGROUND

  • 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. doi: 10.1352/0895-8017(2000)1052.0.CO;2.

    PMID: 10934568BACKGROUND

  • 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. doi: 10.1037//1064-1297.9.3.262.

    PMID: 11534536BACKGROUND

  • 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. doi: 10.1352/0895-8017(2002)1072.0.CO;2.

    PMID: 12069646BACKGROUND

MeSH Terms

Conditions

Psychomotor AgitationIntellectual DisabilitySchizophreniaTardive Dyskinesia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorNeurodevelopmental DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersDyskinesia, Drug-InducedMovement DisordersCentral Nervous System Diseases

Study Officials

  • Karl M Newell, Ph. D.

    Department of Kinesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 21, 2003

First Posted

July 22, 2003

Study Start

December 1, 1996

Study Completion

November 1, 1999

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(2)