A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

New York State Psychiatric Institute

Status and phase

Completed

Phase 4

Conditions

Atypical Depression

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00296699

IRB4943

Details and patient eligibility

About

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

Full 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 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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