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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00208897
First received: September 13, 2005
Last updated: November 8, 2013
Last verified: November 2013
  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

Study Type: Interventional
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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Dr. Christine Heim, Emory University
ClinicalTrials.gov Identifier: NCT00208897     History of Changes
Other Study ID Numbers: IRB00001850, B1Y-MC-X176
Study First Received: September 13, 2005
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Stress, Psychological
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Corticotropin-Releasing Hormone
Fluoxetine
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014