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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Early Life Stress, HPA-axis, CRF

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: For all subjects female gender; For subjects assigned to the MDD groups, current DSM-IV diagnosis of MDD; 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; For all subjects, age of 18 to 45 years; Regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures. Exclusion Criteria: For all subjects, gender identity disorders; For all subjects assigned to non-MDD groups, DSM-IV diagnosis of current MDD; 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; 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; Pregnancy or nursing; For all subjects, past or current presence of psychotic symptoms or bipolar disorder; For all subjects, current presence of psychoactive substance abuse/dependency or eating disorders; For all subjects, hormonal medication; For all subjects, psychotropic medication in the four weeks prior to study entry; For all subjects, inability to provide informed consent.

Sites / Locations

  • Department of Psychiatry and Behavioral Sciences

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
November 8, 2013
Sponsor
Emory University
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00208897
Brief Title
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Emory University
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Early Life Stress, HPA-axis, CRF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Primary Outcome Measure Information:
Title
Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For all subjects female gender; For subjects assigned to the MDD groups, current DSM-IV diagnosis of MDD; 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; For all subjects, age of 18 to 45 years; Regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures. Exclusion Criteria: For all subjects, gender identity disorders; For all subjects assigned to non-MDD groups, DSM-IV diagnosis of current MDD; 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; 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; Pregnancy or nursing; For all subjects, past or current presence of psychotic symptoms or bipolar disorder; For all subjects, current presence of psychoactive substance abuse/dependency or eating disorders; For all subjects, hormonal medication; For all subjects, psychotropic medication in the four weeks prior to study entry; For all subjects, inability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Heim, PhD
Organizational Affiliation
Emory University-Dept. of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Sciences
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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

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