A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

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.

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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.

Conditions

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Atypical Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Cymbalta

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No