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

NCT00208897 | Completed

• 2 other identifiers: IRB00001850B1Y-MC-X176
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Early Life Stress; HPA-axis; CRF

Outcome Measures

Primary Outcomes (1)

• Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF

  6 hours

Secondary Outcomes (1)

• Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being

  8 weeks

Interventions

Fluoxetine DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress, Psychological

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Christine M Heim, PhD

  Emory University-Dept. of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 1997
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

US (1)