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Sponsors and Collaborators: |
Emory University Eli Lilly and Company |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00208897 |
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.
Condition | Intervention |
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Major Depressive Disorder |
Drug: Fluoxetine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | December 1997 |
Estimated Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 488-97, B1Y-MC-X176 |
Study First Received: | September 13, 2005 |
Last Updated: | September 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00208897 |
Health Authority: | United States: Food and Drug Administration |
Early Life Stress HPA-axis CRF |
Fluoxetine Depression Corticotropin-Releasing Hormone Mental Disorders Stress, Psychological Mood Disorders |
Stress Depressive Disorder, Major Depressive Disorder Serotonin Adrenocorticotropic Hormone Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Hormones |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |