Clinical trial NCT00296699: A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
Official title: A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atypical Depression
Keywords: Atypical Depression
Major Depressive Disorder
Dysthymic Disorder
Atypical Features
Duloxetine
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 10 weeks
Secondary outcomes:
measure: Atypical Depression Diagnostic Scale (ADDS)
timeFrame: 10 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 10 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 10 weeks
measure: Patient Global Impression (PGI)
timeFrame: 10 weeks
measure: Inventory of Depressive Symptoms(IDS)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service - New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
name: Jonathan W. Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References: