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

NCT ID: NCT00208897

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-12-31
• Study Completion Date: 2007-11-30

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.

Conditions

Major Depressive Disorder

Keywords

Early Life Stress; HPA-axis; CRF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Fluoxetine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Emory University

Principal Investigators

Christine M Heim, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University-Dept. of Psychiatry and Behavioral Sciences

Locations

Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

B1Y-MC-X176

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00001850

Identifier Type: -

Identifier Source: org_study_id