Atypical Depression Clinical Trial
Official title:
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
NCT number | NCT00296699 |
Other study ID # | IRB4943 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | February 23, 2006 |
Last updated | January 14, 2008 |
Start date | March 2005 |
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Depression Evaluation Service - New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Scale (HAM-D) | 10 weeks | No | |
Secondary | Atypical Depression Diagnostic Scale (ADDS) | 10 weeks | No | |
Secondary | Beck Depression Inventory (BDI) | 10 weeks | No | |
Secondary | Clinical Global Impression (CGI) | 10 weeks | No | |
Secondary | Patient Global Impression (PGI) | 10 weeks | No | |
Secondary | Inventory of Depressive Symptoms(IDS) | 10 weeks | No |
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