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Cymbalta for Depression as a Complication of Bereavement

Primary Purpose

Depression, Bereavement

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Drug treatment with Cymbalta
Sponsored by
Jefferson Clinic, P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Bereavement, Pilot Projects, Antidepressant Drugs

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jefferson Clinic, PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

17-item Hamilton Rating Scale for Depression (HRSD-17)

Secondary Outcome Measures

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):

Full Information

First Posted
April 10, 2008
Last Updated
February 10, 2010
Sponsor
Jefferson Clinic, P.C.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00658931
Brief Title
Cymbalta for Depression as a Complication of Bereavement
Official Title
Cymbalta for Depression as a Complication of Bereavement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Jefferson Clinic, P.C.
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bereavement
Keywords
Depression, Bereavement, Pilot Projects, Antidepressant Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Drug treatment with Cymbalta
Other Intervention Name(s)
Duloxetine Hydrochloride
Intervention Description
Drug treatment with Cymbalta
Primary Outcome Measure Information:
Title
17-item Hamilton Rating Scale for Depression (HRSD-17)
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Texas Revised Inventory of Grief (TRIG)
Time Frame
Eight weeks
Title
Prolonged Grief Disorder (PG-13) Measure
Time Frame
Eight weeks
Title
Clinical Global Impressions - Severity of Illness (CGI-S)
Time Frame
Eight weeks
Title
Clinical Global Impressions - Improvement (CGI-I)
Time Frame
Eight weeks
Title
Mini-Mental State Examination (MMSE)
Time Frame
Eight weeks
Title
Edmonton Symptom Assessment System (ESAS)
Time Frame
Eight weeks
Title
Medical Outcomes Study 12-item Short Form Health Survey (SF-12v2):
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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: Hepatic impairment or insufficiency, Hyponatremia, Narrow-angle glaucoma, History of seizures, Unstable hypertension, OR Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Shuster, MD
Organizational Affiliation
Jefferson Clinic, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Clinic, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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Cymbalta for Depression as a Complication of Bereavement

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