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 range
18 Years – 60 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00065286
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)