Cymbalta for Depression as a Complication of Bereavement
Information source: Jefferson Clinic, P.C.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Bereavement
Intervention: Drug treatment with Cymbalta (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Jefferson Clinic, P.C. Official(s) and/or principal investigator(s): John L Shuster, MD, Principal Investigator, Affiliation: Jefferson Clinic, PC
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).
Clinical Details
Official title: Cymbalta for Depression as a Complication of Bereavement
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 17-item Hamilton Rating Scale for Depression (HRSD-17)
Secondary outcome: Texas Revised Inventory of Grief (TRIG)Prolonged Grief Disorder (PG-13) Measure Clinical Global Impressions - Severity of Illness (CGI-S) Clinical Global Impressions - Improvement (CGI-I) Mini-Mental State Examination (MMSE) Edmonton Symptom Assessment System (ESAS) Medical Outcomes Study 12-item Short Form Health Survey (SF-12v2):
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 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).
This pilot study is an eight-week, open-label clinical antidepressant treatment trial using
Cymbalta (duloxetine hydrochloride) in doses between 20mg and 60mg daily for patients with
co-morbid depression and bereavement. Twenty (20) patients who have sustained the loss of a
first-degree relative (spouse, child, parent, or sibling) within the past two years AND meet
criteria for a major depressive episode at the time of screening will be recruited for
participation in this study. Patients who tolerate and respond to Cymbalta treatment will
be offered maintenance therapy with Cymbalta for up to one year at the effective dose. We
expect that Cymbalta treatment will be associated with substantial remission and response
rates, as measured by HRSD-17 scores. Similarly, we expect substantial mean reductions in
measures of grief and bereavement, with improvements in measures of pain, symptom burden,
and functional status.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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:
1. at least two months must have passed since the death prior to enrollment in the
study, OR
2. 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 Criteria:
- 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:
1. Hepatic impairment or insufficiency,
2. Hyponatremia,
3. Narrow-angle glaucoma,
4. History of seizures,
5. Unstable hypertension, OR
6. Pregnancy.
Locations and Contacts
Jefferson Clinic, PC, Birmingham, Alabama 35233, United States
Additional Information
Starting date: April 2008
Last updated: February 10, 2010
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