Major Depressive DisorderNCT00208897
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
A study testing Fluoxetine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fluoxetine
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, 30322
About this study
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
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.
Read the 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
- Being tested
- Fluoxetine
- Keywords
- Early Life Stress, HPA-axis, CRF
- Medical subject headings
- Depressive Disorder, Major, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
Measured: 6 hours
Secondary outcomes (1)
Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 1997
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Christine M Heim, PhD, Principal investigator, Emory University-Dept. of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208897
- Sponsor's protocol ID
- IRB00001850
- Other IDs
- B1Y-MC-X176
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00208897
- Acronym / sponsor ID
- IRB00001850
- Conditions
- Major Depressive Disorder
- Keywords
- Early Life Stress, HPA-axis, CRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 1997
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine | Drug | – |
Primary outcome
Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
Time frame: 6 hours
1 secondary outcome
Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Heim, PhD principal investigator
Emory University-Dept. of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.