Akathisia Clinical Trial
Official title:
Movement Dynamic Analyses of Akathisia
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.
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.
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Observational Model: Defined Population, Time Perspective: Longitudinal
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