Cymbalta for Depression as a Complication of Bereavement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Jefferson Clinic, P.C..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Jefferson Clinic, P.C.
ClinicalTrials.gov Identifier:
NCT00658931
First received: April 10, 2008
Last updated: February 10, 2010
Last verified: February 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cymbalta for Depression as a Complication of Bereavement

Resource links provided by NLM:


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
Experimental: Treatment Drug: Drug treatment with Cymbalta
Drug treatment with Cymbalta
Other Name: Duloxetine Hydrochloride

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Jefferson Clinic, PC
Birmingham, Alabama, United States, 35233
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: John L. Shuster, Jr., MD, Jefferson Clinic, PC
ClinicalTrials.gov Identifier: NCT00658931     History of Changes
Other Study ID Numbers: FIJ-US-X047
Study First Received: April 10, 2008
Last Updated: February 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Jefferson Clinic, P.C.:
Depression
Bereavement
Pilot Projects
Antidepressant Drugs

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014