Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
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 (i.e. childhood sexual and/or physical abuse) in cases with and without major depression. We also evaluate whether neuroendocrine changes after SSRI treatment correlate with clinical improvement.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 1997|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
We compare indices of central CRF activity (i.e. 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 (ELS/MDD), women with a history of childhood abuse without major depression (ELS/non-MDD), and women without a history of childhood abuse and major depression (non-ELS/MDD). 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208897
|United States, Georgia|
|Department of Psychiatry and Behavioral Sciences|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Christine M Heim, PhD||Emory University-Dept. of Psychiatry and Behavioral Sciences|