Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004486
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Fluoxetine in Children and Adolescents With Autism
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-12
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 Evaluate the efficacy of fluoxetine on social and language deficits global severity and compulsive dimensions of children and adolescents with autism
II Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population
III Compare the baseline compulsive severity and treatment outcome in these patients
II Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population
III Compare the baseline compulsive severity and treatment outcome in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled crossover study All patients receive oral placebo daily during week 0
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8 Patients then crossover to receive treatment on the other arm during weeks 12-20
Completion date provided represents the completion date of the grant per OOPD records
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8 Patients then crossover to receive treatment on the other arm during weeks 12-20
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MTS-GCO-96-713 | None | None | None |
| MTS-FDR001520 | None | None | None |