Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000373
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
1999-11-02
Brief Title:
Treatment of Obsessive-Compulsive Disorder
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
NeurobiologyTreatment of Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The purpose of this study is to find the best treatment for Tourettes Syndrome TS-spectrum obsessive-compulsive disorder OCD which includes symptoms of TS eg repeated and involuntary body movements tics
There are 2 parts to this study In Part 1 patients are placed into 1 of 2 groups based on type of OCD determined by medical history and family member interviews In Part 2 patients are treated with fluvoxamine FVX for 8 weeks If patients do not respond to FVX alone either haloperidol or an inactive placebo will be added to the FVX regimen patients will take this drug combination for 4 weeks Patients will be monitored throughout the trial
There are 2 parts to this study In Part 1 patients are placed into 1 of 2 groups based on type of OCD determined by medical history and family member interviews In Part 2 patients are treated with fluvoxamine FVX for 8 weeks If patients do not respond to FVX alone either haloperidol or an inactive placebo will be added to the FVX regimen patients will take this drug combination for 4 weeks Patients will be monitored throughout the trial
Detailed Description:
To advance the neurobiology and treatment of obsessive-compulsive disorder OCD by focusing on Tourettes Syndrome TS-spectrum OCD as a possible homogeneous form of OCD and investigating the relevance of intact 5-hydroxytryptamine 5-HT function to the mechanism of anti-OC drug action The validity of TS-spectrum OCD as a distinct subtype is assessed using a detailed clinical family drug treatment response profile in adult OCD patients
In Study I patients are divided prospectively into 2 putative subtypes TS-spectrum and non-TS-spectrum OCD on the basis of clinical history and direct structured interviews of family members approximately 400 interviews
In Study II patients enter an 8-week single-blind trial with the potent and selective 5-HT reuptake inhibitor fluoxetine FX Patients with an incomplete response to FX alone approximately 64 patients are randomized to a 4-week double-blind trial of FX in combination with the dopamine DA 2 antagonist olanzapine OLA or placebo PLA
In Study I patients are divided prospectively into 2 putative subtypes TS-spectrum and non-TS-spectrum OCD on the basis of clinical history and direct structured interviews of family members approximately 400 interviews
In Study II patients enter an 8-week single-blind trial with the potent and selective 5-HT reuptake inhibitor fluoxetine FX Patients with an incomplete response to FX alone approximately 64 patients are randomized to a 4-week double-blind trial of FX in combination with the dopamine DA 2 antagonist olanzapine OLA or placebo PLA
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 |
|---|---|---|---|
| R01MH045802 | NIH | None | httpsreporternihgovquickSearchR01MH045802 |