Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208897
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2005-09-13
Brief Title:
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Does Fluoxetine Reverse the Effects of Early Life Stress on the CNS Corticotropin-Releasing Factor System and Improve Psychological and Neuroendocrine Function A Therapy Outcome Study in Women With Childhood Abuse Experiences
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 primary objective of this project is to determine whether treatment with the SSRI fluoxetine versus placebo reverses alterations in the central CRF system induced by early life stress experiences ie childhood sexual andor physical abuse in cases with and without major depression We also evaluate whether neuroendocrine changes after SSRI treatment correlate with clinical improvement
Detailed Description:
We compare indices of central CRF activity ie ACTH and cortisol response to CRF stimulation test before and after 8 weeks of treatment with either fluoxetine or placebo between women with a history of childhood abuse early life stress ELS and current major depression ELSMDD women with a history of childhood abuse without major depression ELSnon-MDD and women without a history of childhood abuse and major depression non-ELSMDD Changes in neuroendocrine responses to CRF are correlated with psychological outcome measures We hypothesize that treatment with fluoxetine will normalize altered neuroendocrine responsiveness in cases with ELS and that this normalization will be correlated with improvement of symptoms of depression and anxiety
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 |
|---|---|---|---|
| B1Y-MC-X176 | OTHER | Other | None |