Major Depressive DisorderPhase 4NCT00166114
Depression, Epinephrine, and Platelet Function
A Phase 4 study testing Escitalopram and Desipramine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.
Trial summary
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram and Desipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- Individuals who are suicidal, psychotic, or with bipolar depression
- alcohol or substance abuse or
- regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
- have narrow-angle glaucoma, liver disease,
- severe allergies (especially to antidepressants similar to escitalopram or desipramine)
- seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
- Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: Do Antidepressants Reverse the Effects of Early Life Stress on the Brain and Thrombovascular System and Improve Psychological, Neuroendocrine, and Platelet Function: A Study of Men and Women With Childhood Abuse.
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Desipramine
- Keywords
- platelet function, childhood abuse, depression, antidepressants, immune function, stress response
- Medical subject headings
- Depressive Disorder, Major, Depression, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
DesipramineDrug
Also called Norpramin
25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Active comparator | Not described Receives: Drug: Escitalopram |
| Desipramine | Active comparator | Not described Receives: Drug: Desipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.
The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:
No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dominique Musselman, Emory University
- Investigators
- Dominique L Musselman, MD,MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166114
- Sponsor's protocol ID
- 0473-2002
- Other IDs
- 1R01HL065523-01A2
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2005
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Royster EB, Trimble LM, Cotsonis G, Schmotzer B, Manatunga A, Rushing NN, Pagnoni G, Auyeung SF, Brown AR, Schoenbeck J, Murthy S, McDonald WM, Musselman DL. Changes in heart rate variability of depressed patients after electroconvulsive therapy. Cardiovasc Psychiatry Neurol. 2012;2012:794043. doi: 10.1155/2012/794043. Epub 2012 Aug 27.
PubMed 22966422Shively CA, Musselman DL, Willard SL. Stress, depression, and coronary artery disease: modeling comorbidity in female primates. Neurosci Biobehav Rev. 2009 Feb;33(2):133-44. doi: 10.1016/j.neubiorev.2008.06.006. Epub 2008 Jun 24.
PubMed 18619999Bruce EC, Musselman DL. Depression, alterations in platelet function, and ischemic heart disease. Psychosom Med. 2005 May-Jun;67 Suppl 1:S34-6. doi: 10.1097/01.psy.0000164227.63647.d9.
PubMed 15953798Bruce EC, Guo Y, Lawson KC, Manatunga AK, Auyeung SF, McDonald WM, Rushing N, Brown AR, Gilles N, Emery M, Bonsall R, Porquez J, Stowe Z, Nemeroff CB, Musselman DL. Platelet thromboxane A2 secretion in patients with major depression responsive to electroconvulsive therapy. Psychosom Med. 2008 Apr;70(3):319-27. doi: 10.1097/PSY.0b013e3181663580. Epub 2008 Mar 31.
PubMed 18378867
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Antidepressants Reverse the Effects of Early Life Stress on the Brain and Thrombovascular System and Improve Psychological, Neuroendocrine, and Platelet Function: A Study of Men and Women With Childhood Abuse.
- ClinicalTrials.gov ID
- NCT00166114
- Acronym / sponsor ID
- 0473-2002
- Conditions
- Major Depressive Disorder
- Keywords
- platelet function, childhood abuse, depression, antidepressants, immune function, stress response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2002
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Active comparator | Drug: Escitalopram |
| Desipramine | Active comparator | Drug: Desipramine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (7 listed)
- Individuals who are suicidal, psychotic, or with bipolar depression
- alcohol or substance abuse or
- regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
- have narrow-angle glaucoma, liver disease,
- severe allergies (especially to antidepressants similar to escitalopram or desipramine)
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 |
|---|---|---|
| EscitalopramAlso: Lexapro10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention | Drug | Escitalopram |
| DesipramineAlso: Norpramin25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention | Drug | Desipramine |
Primary outcome
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
Time frame: Baseline, Week 8
Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8. The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table: No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22966422Royster EB, Trimble LM, Cotsonis G, Schmotzer B, Manatunga A, Rushing NN, Pagnoni G, Auyeung SF, Brown AR, Schoenbeck J, Murthy S, McDonald WM, Musselman DL. Changes in heart rate variability of depressed patients after electroconvulsive therapy. Cardiovasc Psychiatry Neurol. 2012;2012:794043. doi: 10.1155/2012/794043. Epub 2012 Aug 27.
- Background: PubMed 18619999Shively CA, Musselman DL, Willard SL. Stress, depression, and coronary artery disease: modeling comorbidity in female primates. Neurosci Biobehav Rev. 2009 Feb;33(2):133-44. doi: 10.1016/j.neubiorev.2008.06.006. Epub 2008 Jun 24.
- Background: PubMed 15953798Bruce EC, Musselman DL. Depression, alterations in platelet function, and ischemic heart disease. Psychosom Med. 2005 May-Jun;67 Suppl 1:S34-6. doi: 10.1097/01.psy.0000164227.63647.d9.
- Results publication: PubMed 18378867Bruce EC, Guo Y, Lawson KC, Manatunga AK, Auyeung SF, McDonald WM, Rushing N, Brown AR, Gilles N, Emery M, Bonsall R, Porquez J, Stowe Z, Nemeroff CB, Musselman DL. Platelet thromboxane A2 secretion in patients with major depression responsive to electroconvulsive therapy. Psychosom Med. 2008 Apr;70(3):319-27. doi: 10.1097/PSY.0b013e3181663580. Epub 2008 Mar 31.
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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.
Dominique L Musselman, MD,MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram and Desipramine 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 1 inclusion and 7 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 23 Jul 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166114, which also lists 4 linked publications.
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 23 Jul 2015.