Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation (NCT00065286) | Clinical Trial Compass
CompletedNot Applicable
Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation
United StatesStarted 1996-12
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Trial details
NCT IDNCT00065286
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)