NCT00296699CompletedPhase 4
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
New York State Psychiatric Institute1 site in 1 country20 target enrollmentStarted: March 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Scale (HAM-D)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Hamilton Depression Scale (HAM-D)
Time Frame: 10 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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