A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedJanuary 15, 2008
January 1, 2008
2.3 years
February 23, 2006
January 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Scale (HAM-D)
10 weeks
Secondary Outcomes (5)
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
Interventions
Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d. \* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- Eli Lilly and Companycollaborator
Study Sites (1)
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan W. Stewart, M.D.
New York State Psychiatric Institute - Columbia University Department of Psychiatry
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
March 1, 2005
Primary Completion
June 1, 2007
Last Updated
January 15, 2008
Record last verified: 2008-01