A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Completed · Phase 4

Conditions studied: Atypical Depression

In brief

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

Key facts

Study ID

NCT00296699

Run by

New York State Psychiatric Institute

People needed

20

Starts

2005-03-01

Last updated by the study team

2008-01-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Depression Evaluation Service - New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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