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Duloxetine for the Treatment of Dysthymia

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ClinicalTrials.gov Identifier: NCT00185575
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 9, 2009
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Stanford University

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date April 9, 2009
Study Start Date  ICMJE September 2004
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Inventory of Depressive Symptomatology (Clinician-Rated)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Clinical Global Impressions - Improvement
  • Zung Self-Rating Depression Scale
  • Patient Global Improvement
  • Brief Pain Inventory
  • WHO-QOL 100
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duloxetine for the Treatment of Dysthymia
Official Title  ICMJE Duloxetine for the Treatment of Dysthymia
Brief Summary The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.
Detailed Description

The purpose of this research is to obtain information on the safety and effectiveness of duloxetine (Cymbalta) in the treatment of dysthymia. Duloxetine has been approved by the federal Food and Drug Administration for the treatment of depression. The use of duloxetine for treatment of dysthymia is considered experimental.

Dysthymia is defined as chronic, low-grade depression, characterized by feeling low or depressed, that lasts for two or more years. Additional symptoms may include: poor appetite or overeating; insomnia or sleeping too much; low energy or fatigue; low self-esteem; poor concentration or difficulty making decisions; and feelings of hopelessness.

Dysthymia affects 3-6% of the general population, but is an underdiagnosed and undertreated disorder. In double-blind, placebo-controlled clinical trials of antidepressant medications, dysthymia response rates are around 60%, compared to an average placebo response rate of about 30%. Duloxetine has not been studied in the treatment of dysthymia, but has shown results in the treatment of major depression. In a 9-week, double-blind, placebo-controlled study of 257 patients with major depression, 65% responded to duloxetine 60mg/day, compared to 43% to placebo. Based on these results, it is highly likely that duloxetine will be an effective treatment for dysthymia.

This research study is being conducted at Stanford University Medical Center with a total of 24 patients, age 18 and above, with dysthymia.

In the study, subjects will receive duloxetine for 12 weeks. This is an open-label study, which means that every subject receives the study medication.

In total, subjects are seen for 10 visits across 13 weeks. At each visit subjects' heart rate, blood pressure and weight measurements will be obtained. At each visit study personnel will interview subjects about their symptoms, monitor side effects and ask them to complete study questionnaires.

Beginning at the second visit, subjects receive duloxetine 60 mg/day. If they experience side effects, the dose can be decreased to 30 mg/day for several days, but will be increased back to 60 mg/day by the end of the first week. If subjects are unable to tolerate a dose of 60 mg/day due to side effects, they will be withdrawn from the study. At the end of 6 weeks, if they have not responded to the study medication (as determined by doctor ratings based on subjects' reports), the dose of duloxetine will be increased to 120 mg/day, unless subjects are experiencing troubling side effects. Subjects continue on the minimum dose that brings about remission or the maximum tolerated dose for the remaining 6 weeks. Medication dosing will be flexible and determined by tolerance (side effects) and therapeutic effect.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE Drug: duloxetine
Study Arms  ICMJE Not Provided
Publications * Koran LM, Aboujaoude EN, Gamel NN. Duloxetine treatment of dysthymia and double depression: an open-label trial. J Clin Psychiatry. 2007 May;68(5):761-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 9, 2005)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria::

  • Sign an informed consent form
  • 18 years of age or older
  • Females not pregnant or breastfeeding or planning pregnancy and using an acceptable form of contraception
  • Meet DSM-IV criteria for dysthymia
  • A screening IDS-C score of 17 or greater
  • No history of serious or unstable medical disorder
  • Not taking any significant concurrent medications
  • Not currently receiving psychotherapy Exclusion Criteria:- Suffering from DSM-IV defined
  • delirium, dementia, amnestic, or other cognitive disorders
  • mental disorders due to a general medical condition
  • factitious or somatoform disorders
  • mental retardation or developmental disabilities
  • substance or alcohol abuse within the last 3 months
  • depressive disorders with current suicidal risk
  • psychotic disorders including delusional disorder, somatic type
  • dissociative disorder
  • personality disorders sufficiently severe to interfere with study participation
  • History of DSM-IV defined bipolar I or II disorder
  • History of non-response of dysthymia to adequate antidepressant medication
  • History of major depression refractory to two adequate trials of antidepressants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00185575
Other Study ID Numbers  ICMJE SUSPO30478
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lorrin M Koran, Principal Investigator, Stanford University School of Medicine
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Lorrin M Koran Stanford University
PRS Account Stanford University
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP