Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004446
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Study of Fluoxetine in Patients With Depersonalization Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
The purpose of this study is to
1 Determine the effects of fluoxetine in the treatment of depersonalization disorder 2 Assess the durability of treatment response in these patients 3 Assess the improvement in psychiatric disability in these patients and 4 Assess the effects of comorbid Axis I disorders depression social phobia panicanxiety obsessive-compulsive disorder and Axis II personality disorders on treatment outcome in these patients
1 Determine the effects of fluoxetine in the treatment of depersonalization disorder 2 Assess the durability of treatment response in these patients 3 Assess the improvement in psychiatric disability in these patients and 4 Assess the effects of comorbid Axis I disorders depression social phobia panicanxiety obsessive-compulsive disorder and Axis II personality disorders on treatment outcome in these patients
Detailed Description:
In this trial participants will be randomly assigned to receive either fluoxetine or placebo Treatment will consists of two phases acute treatment and maintenance In the acute treatment phase participants will receive fluoxetine or placebo daily for 12 weeks Participants will be followed every 2 weeks In the Maintenance phase participants showing significant improvement after 12 weeks may continue treatment for an additional 6 months In this phase participants are followed every 4 weeks
Participants who do not improve during the acute treatment phase may receive open fluoxetine or another appropriate medication for 3 months
Participants who do not improve during the acute treatment phase may receive open fluoxetine or another appropriate medication for 3 months
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-95-323 | None | None | None |