Cymbalta for Depression as a Complication of Bereavement
Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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 daily for eight (8) weeks. The primary outcome measure for this study will
be the 17-item Hamilton Rating Scale for Depression (HRSD-17). In pursuit of this objective,
we will test the following hypothesis: After eight weeks of open-label treatment with
Cymbalta for bereavement-associated depression, at least half of the participants will
achieve remission, as measured by a score of 7 or less on the HRSD-17.
Secondary objectives of this project are:
- To determine the tolerability of Cymbalta treatment among patients with
bereavement-associated depression (as measured by adverse events and the proportion of
participants who discontinue Cymbalta before completing eight weeks of study treatment);
- To determine the effect of Cymbalta treatment on grief in patients with
bereavement-associated depression (as measured by the Texas Revised Inventory of Grief
and the Inventory of Complicated Grief after eight weeks of treatment compared to
baseline); and
- To determine the effect of Cymbalta treatment on health status, pain, and other
co-morbid symptoms in patients with bereavement-associated depression (as measured by
the Edmonton Symptom Assessment System and the Medical Outcomes Study 12-item Short Form
Health Survey administered at Weeks 2, 4, and 8 and compared to baseline).