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Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?

This study has been completed.
Eli Lilly and Company
Information provided by:
Emory University Identifier:
First received: September 13, 2005
Last updated: November 8, 2013
Last verified: November 2013
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
Major Depressive Disorder
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being [ Time Frame: 8 weeks ]

Estimated Enrollment: 80
Study Start Date: December 1997
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:
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   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. For all subjects female gender;
  2. For subjects assigned to the MDD groups, current DSM-IV diagnosis of MDD;
  3. For subjects assigned to the early-life stress group, repeated (once per month or more for at least year) sexual or physical abuse before the age of 12 years by a perpetrator at least 5 years older at the time;
  4. For all subjects, age of 18 to 45 years;
  5. Regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures.

Exclusion Criteria:

  1. For all subjects, gender identity disorders;
  2. For all subjects assigned to non-MDD groups, DSM-IV diagnosis of current MDD;
  3. For all subjects assigned to the group without early-life stress, major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness or natural disaster;
  4. For all subjects, significant medical illness, such as gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ECG, and laboratory tests;
  5. Pregnancy or nursing;
  6. For all subjects, past or current presence of psychotic symptoms or bipolar disorder;
  7. For all subjects, current presence of psychoactive substance abuse/dependency or eating disorders;
  8. For all subjects, hormonal medication;
  9. For all subjects, psychotropic medication in the four weeks prior to study entry;
  10. For all subjects, inability to provide informed consent.
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Please refer to this study by its identifier: NCT00208897

United States, Georgia
Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Eli Lilly and Company
Principal Investigator: Christine M Heim, PhD Emory University-Dept. of Psychiatry and Behavioral Sciences
  More Information

Responsible Party: Dr. Christine Heim, Emory University Identifier: NCT00208897     History of Changes
Other Study ID Numbers: IRB00001850
B1Y-MC-X176 ( Other Identifier: Other )
Study First Received: September 13, 2005
Last Updated: November 8, 2013

Keywords provided by Emory University:
Early Life Stress

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Corticotropin-Releasing Hormone
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 28, 2017