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

NCT ID: NCT00065286

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-12-31
• Study Completion Date: 1999-11-30

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.

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.

Conditions

Akathisia

Keywords

Akathisia; Mental retardation; Schizophrenia; Neuroleptic medication; Tardive dyskinesia; Brief Psychiatric Rating Scale; Barnes test; Stereotypy Checklist Test; DISCUS Tardive Dyskinesia test

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Karl M Newell, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Department of Kinesiology

Locations

Western Carolina Center

Morganton, North Carolina, United States

Department of Kinesiology

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10349469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10934568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11534536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12069646 (View on PubMed)

Other Identifiers

NICHD-17

Identifier Type: -

Identifier Source: secondary_id

5R01HD034027

Identifier Type: NIH

Identifier Source: secondary_id

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5R01HD034027

Identifier Type: NIH

Identifier Source: org_study_id

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