A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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