A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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

Detailed Description
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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.

Official Title
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A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Conditions
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Atypical Depression

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine