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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208897
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 11, 2013
Eli Lilly and Company
Information provided by:
Emory University

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 (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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Fluoxetine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (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
Study Start Date : December 1997
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208897

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

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Responsible Party: Dr. Christine Heim, Emory University Identifier: NCT00208897     History of Changes
Other Study ID Numbers: IRB00001850
B1Y-MC-X176 ( Other Identifier: Other )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013
Keywords provided by Emory University:
Early Life Stress
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
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