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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208897
• Other study ID #: IRB00001850
• Secondary ID: B1Y-MC-X176
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 8, 2013
• Start date: December 1997
• Est. completion date: November 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Fluoxetine

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF		6 hours	No
Secondary	Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being		8 weeks	No