A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
Phase 4
Completed
- Conditions
- Atypical Depression
- Registration Number
- NCT00296699
- Lead Sponsor
- New York State Psychiatric Institute
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Hamilton Depression Scale (HAM-D) 10 weeks
- Secondary Outcome Measures
Name Time Method Atypical Depression Diagnostic Scale (ADDS) 10 weeks Beck Depression Inventory (BDI) 10 weeks Clinical Global Impression (CGI) 10 weeks Patient Global Impression (PGI) 10 weeks Inventory of Depressive Symptoms(IDS) 10 weeks
Trial Locations
- Locations (1)
Depression Evaluation Service - New York State Psychiatric Institute
🇺🇸New York, New York, United States