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

Akathisia Clinical Trial

Official title:

Movement Dynamic Analyses of Akathisia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065286
• Other study ID #: 5R01HD034027
• Secondary ID: NICHD-175 RO1 HD
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2003
• Last updated: June 23, 2005
• Start date: December 1996
• Est. completion date: November 1999

Study information

• Verified date: June 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Akathisia
• Intellectual Disability

Locations

Country	Name	City	State
United States	Western Carolina Center	Morganton	North Carolina
United States	Department of Kinesiology	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation