Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Fluoxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Emory University Official(s) and/or principal investigator(s): Christine M Heim, PhD, Principal Investigator, Affiliation: Emory University-Dept. of Psychiatry and Behavioral Sciences
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
Secondary outcome: Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
Department of Psychiatry and Behavioral Sciences, Atlanta, Georgia 30322, United States
Additional Information
Starting date: December 1997
Last updated: November 8, 2013
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