Cymbalta for Depression as a Complication of Bereavement

Depression Clinical Trial

Official title:

Cymbalta for Depression as a Complication of Bereavement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00658931
• Other study ID #: FIJ-US-X047
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 10, 2008
• Last updated: February 10, 2010
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2010
• Source: Jefferson Clinic, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bereavement
• Depression
• Depressive Disorder

Intervention

Drug:
• Drug treatment with Cymbalta
Drug treatment with Cymbalta

Locations

Country	Name	City	State
United States	Jefferson Clinic, PC	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Jefferson Clinic, P.C.	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Rating Scale for Depression (HRSD-17)		Eight weeks	Yes
Secondary	Texas Revised Inventory of Grief (TRIG)		Eight weeks	No
Secondary	Prolonged Grief Disorder (PG-13) Measure		Eight weeks	No
Secondary	Clinical Global Impressions - Severity of Illness (CGI-S)		Eight weeks	No
Secondary	Clinical Global Impressions - Improvement (CGI-I)		Eight weeks	No
Secondary	Mini-Mental State Examination (MMSE)		Eight weeks	No
Secondary	Edmonton Symptom Assessment System (ESAS)		Eight weeks	No
Secondary	Medical Outcomes Study 12-item Short Form Health Survey (SF-12v2):		Eight weeks	No