A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Atypical Depression Clinical Trial

Official title:

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296699
• Other study ID #: IRB4943
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2006
• Last updated: January 14, 2008
• Start date: March 2005

Study information

• Verified date: January 2008
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atypical Depression
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Depression Evaluation Service - New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Depression Evaluation Service - official website
•   New York State Psychiatric Institute - official website