Cymbalta for Depression as a Complication of Bereavement - Full Text View

Sponsor:	Jefferson Clinic, P.C.
Collaborator:	Eli Lilly and Company
Information provided by:	Jefferson Clinic, P.C.
ClinicalTrials.gov Identifier:	NCT00658931

Purpose

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).

Condition	Intervention	Phase
Depression Bereavement	Drug: Drug treatment with Cymbalta	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Cymbalta for Depression as a Complication of Bereavement

Resource links provided by NLM:

MedlinePlus related topics: Bereavement Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Jefferson Clinic, P.C.:

Primary Outcome Measures:

17-item Hamilton Rating Scale for Depression (HRSD-17) [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Texas Revised Inventory of Grief (TRIG) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Prolonged Grief Disorder (PG-13) Measure [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Clinical Global Impressions - Severity of Illness (CGI-S) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Mini-Mental State Examination (MMSE) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Edmonton Symptom Assessment System (ESAS) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study 12-item Short Form Health Survey (SF-12v2): [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental	Drug: Drug treatment with Cymbalta Drug treatment with Cymbalta

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658931

Contacts

Contact: Michael Johnson

205-521-6211

mjohnson@jeffersonclinic.com

Locations

United States, Alabama
Jefferson Clinic, PC	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Michael Johnson 205-521-6211 mjohnson@jeffersonclinic.com
Principal Investigator: John L Shuster, MD

Sponsors and Collaborators

Jefferson Clinic, P.C.

Eli Lilly and Company

Investigators

Principal Investigator:

John L Shuster, MD

Jefferson Clinic, PC

More Information

No publications provided

Responsible Party:	Jefferson Clinic, PC ( John L. Shuster, Jr., MD )
Study ID Numbers:	FIJ-US-X047
Study First Received:	April 10, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00658931 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Jefferson Clinic, P.C.:

Depression
Bereavement
Pilot Projects
Antidepressant Drugs

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 05, 2009