Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004300
Status:
SUSPENDED
Last Update Posted:
2010-10-06
First Post:
1999-10-18
Brief Title:
Phase II Study of Stereotypes and Mental Retardation Neurobiological Basis
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase II Study of Stereotypes and Mental Retardation Neurobiological Basis
Status:
SUSPENDED
Status Verified Date:
2006-03
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:
OBJECTIVES I Determine differences between persons with repetitive behavior disorders and matched controls on measures of motor control relevant to basal ganglia pathophysiology
II Determine the efficacy of bromocriptine a dopamine agonist in the treatment of stereotyped behavior and related behavior disorders
III Determine the efficacy of sertraline hydrochloride a selective serotonin uptake inhibitor in the treatment of repetitive behavior disorders
IV Identify behavioral environmental and biological variables with differential drug treatment response
II Determine the efficacy of bromocriptine a dopamine agonist in the treatment of stereotyped behavior and related behavior disorders
III Determine the efficacy of sertraline hydrochloride a selective serotonin uptake inhibitor in the treatment of repetitive behavior disorders
IV Identify behavioral environmental and biological variables with differential drug treatment response
Detailed Description:
PROTOCOL OUTLINE Motor slowness bradykinesia and motor control are tested in repetitive behavior disorder patients and matched controls Group differences reflecting alterations in basal ganglia dopamine function are compared
Behavioral assessments are conducted on each patient by trained observers Assessments are taken at baseline and during the maintenance phase of drug treatment described below
The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized double blind placebo controlled crossover study extending over 20 weeks Cohorts of 6 to 8 patients first enter into a single blind placebo phase followed by double blind treatment with placebo or bromocriptine The crossover manipulation entails a titration phase a maintenance phase then a final single blind placebo condition
The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions Duration of study is 26 weeks
Behavioral assessments are conducted on each patient by trained observers Assessments are taken at baseline and during the maintenance phase of drug treatment described below
The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized double blind placebo controlled crossover study extending over 20 weeks Cohorts of 6 to 8 patients first enter into a single blind placebo phase followed by double blind treatment with placebo or bromocriptine The crossover manipulation entails a titration phase a maintenance phase then a final single blind placebo condition
The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions Duration of study is 26 weeks
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 |
|---|---|---|---|
| UF-63394 | None | None | None |