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A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00296699
First received: February 23, 2006
Last updated: January 14, 2008
Last verified: January 2008

February 23, 2006
January 14, 2008
March 2005
June 2007   (final data collection date for primary outcome measure)
Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Hamilton Depression Scale (HAM-D)
Complete list of historical versions of study NCT00296699 on ClinicalTrials.gov Archive Site
  • Atypical Depression Diagnostic Scale (ADDS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression (PGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptoms(IDS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Atypical Depression Diagnostic Scale (ADDS)
  • Beck Depression Inventory (BDI)
  • Clinical Global Impression (CGI)
  • Patient Global Impression (PGI)
  • Inventory of Depressive Symptoms(IDS)
Not Provided
Not Provided
 
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.

This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atypical Depression
Drug: Duloxetine

Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d.

* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.

Other Name: Cymbalta
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV Major Depression or Dysthymia with Atypical Features
  • Age 18-65
  • Physically healthy
  • HAMD(24) > 14

Exclusion Criteria:

  • Prior experience with Duloxetine
  • History of Psychosis or Bipolar Disorder, Borderline Personality Disorder
  • Unstable medical disorder; any history of Epilepsy
  • Currently taking medication that can interact with Duloxetine
  • Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
  • Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
  • Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine)
  • Pregnancy
  • Currently breast feeding
  • Fecund women failing to use acceptable birth control
  • Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode)
  • Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma)
  • Currently taking medication deemed effective
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296699
IRB4943
Not Provided
Jonathon W. Stewart, New York State Psychiatric Institute
New York State Psychiatric Institute
Eli Lilly and Company
Principal Investigator: Jonathan W. Stewart, M.D. New York State Psychiatric Institute - Columbia University Department of Psychiatry
New York State Psychiatric Institute
January 2008

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