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Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Emory University
Eli Lilly and Company
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00208897
  Purpose

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

MedlinePlus related topics: Depression Stress
Drug Information available for: Fluoxetine Corticotropin Fluoxetine hydrochloride Corticotropin-releasing hormone
U.S. FDA Resources
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

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

Secondary Outcome Measures:
  • Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being

Estimated Enrollment: 80
Study Start Date: December 1997
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208897

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

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

Keywords provided by Emory University:
Early Life Stress
HPA-axis
CRF

Study placed in the following topic categories:
Fluoxetine
Depression
Corticotropin-Releasing Hormone
Mental Disorders
Stress, Psychological
Mood Disorders
Stress
Depressive Disorder, Major
Depressive Disorder
Serotonin
Adrenocorticotropic Hormone
Behavioral Symptoms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009