Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065286
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-21
Brief Title:
Akathisia Restless Legs Syndrome in People With Schizophrenia and Mental Retardation
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Movement Dynamic Analyses of Akathisia
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NICHD-17 | None | None | None |
| 5R01HD034027 | NIH | None | httpsreporternihgovquickSearch5R01HD034027 |