Status:
UNKNOWN
Cymbalta for Depression as a Complication of Bereavement
Lead Sponsor:
Jefferson Clinic, P.C.
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depression
Bereavement
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for bereavement-associated depression. Participating patients will be treated with Cymbalta in doses up to 60mg dail...
Detailed Description
The primary objective of this pilot project is to evaluate the efficacy of Cymbalta for bereavement-associated depression. Participating patients will be treated with Cymbalta in doses up to 60mg dail...
Eligibility Criteria
Inclusion
- Must have sustained the loss of a first-degree relative (spouse, partner, child, parent, sibling, or person otherwise described by the patient as a first-degree relative) within the past two years and one of the two following features must also be present:
- at least two months must have passed since the death prior to enrollment in the study, OR
- there must be evidence of marked functional impairment (as defined in the DSM-IV description of Bereavement, v62.82);
- Must meet criteria for a major depressive episode as defined in DSM-IV;
- Onset of this depressive episode must have occurred after the death of the first-degree relative (if the relative's death was unexpected) OR no more then three months prior to the death of the relative (if the relative's death was expected);
- HRSD-17 score of \>17 at baseline assessment;
- Must be in stable medical health;
- Must be able to communicate in English; AND
- Must be willing and able to travel to the Cooper Green Mercy Hospital or the Jefferson Clinic, PC for evaluations according to the study protocol.
Exclusion
- History of Dysthymic Disorder or a depressive episode preceding the death of the first-degree relative by more than three months;
- History or symptoms of mania or psychosis (e.g., bipolar disorders, schizophrenia and other psychotic disorders);
- Evidence of current alcohol or other substance abuse or dependence;
- Evidence of clinically significant dementia or cognitive impairment (from history or a score on the screening Mini Mental State Exam of 23 or less);
- Concomitant use of other antidepressants (patients can be enrolled after taper and clearance of other antidepressant medications);
- Concomitant use of medications known to have potential for clinically significant interaction with Cymbalta (patients can be enrolled after taper and clearance of other medications, if other medications can be safely discontinued).
- Suicidal thoughts with intent or plan, or other situations where the patient is judged to be a high risk of suicide;
- Known hypersensitivity to Cymbalta or any of its inactive ingredients;
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug; OR
- Any of the following medical conditions present:
- Hepatic impairment or insufficiency,
- Hyponatremia,
- Narrow-angle glaucoma,
- History of seizures,
- Unstable hypertension, OR
- Pregnancy.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00658931
Start Date
April 1 2008
End Date
April 1 2010
Last Update
February 12 2010
Active Locations (1)
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1
Jefferson Clinic, PC
Birmingham, Alabama, United States, 35233