Status:
COMPLETED
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Atypical Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- DSM-IV Major Depression or Dysthymia with Atypical Features
- Age 18-65
- Physically healthy
- HAMD(24) \> 14
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00296699
Start Date
March 1 2005
Last Update
January 15 2008
Active Locations (1)
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1
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032