Duloxetine for Chronic Depression: a Double-blind Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00360724
First received: August 3, 2006
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).

Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.

Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.


Condition Intervention Phase
Dysthymic Disorder
Depressive Disorder NOS
Drug: Duloxetine (Cymbalta)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duloxetine for Chronic Depression: a Double-blind Study

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cornell Dysthymia Rating Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging, Anatomical [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging, Functional [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Magnetic Resonance Spectroscopy [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Improvement(CGI-I) [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: duloxetine (cymbalta)
Duloxetine medication
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
  • duloxetine
  • Cymbalta
Placebo Comparator: 2
placebo treatment
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
  • duloxetine
  • Cymbalta

Detailed Description:

This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have dysthymic disorder (dysthymia) or depression, type not otherwise specified ('depression NOS').

The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.

Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.

In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, fMRI, MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 20 to 75 years (ages 20 to 60 for MRI sub-study)
  • diagnosis of dysthymic disorder (chronic depression) or depression NOS
  • minimum of 2 years duration of current episode of depression

Exclusion Criteria:

  • current major depression
  • diagnoses including delirium, dementia, bipolar disorder, schizophrenia
  • substance abuse or dependence in the past 6 months
  • pregnant or nursing women
  • serious risk of suicide
  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: NCT00360724

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Eli Lilly and Company
Investigators
Principal Investigator: David J. Hellerstein, MD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00360724     History of Changes
Other Study ID Numbers: NYSPI IRB# 4967
Study First Received: August 3, 2006
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
dysthymia
dysthymic disorder
chronic depression
chronic low-grade depression
atypical depression
minor depression
depression NOS
depression
depressive disorder
mood disorder
unipolar depression
low-grade depression

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

ClinicalTrials.gov processed this record on September 29, 2014