A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by:

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT00296699

First received: February 23, 2006

Last updated: January 14, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2006

Last Updated Date

January 14, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Hamilton Depression Scale (HAM-D)

Change History

Complete list of historical versions of study NCT00296699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Atypical Depression Diagnostic Scale (ADDS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Patient Global Impression (PGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Inventory of Depressive Symptoms(IDS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Atypical Depression Diagnostic Scale (ADDS)
Beck Depression Inventory (BDI)
Clinical Global Impression (CGI)
Patient Global Impression (PGI)
Inventory of Depressive Symptoms(IDS)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Official Title ^ICMJE

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Atypical Depression

Intervention ^ICMJE

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.

Other Name: Cymbalta

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00296699

Other Study ID Numbers ^ICMJE

IRB4943

Has Data Monitoring Committee

Not Provided

Responsible Party

Jonathon W. Stewart, New York State Psychiatric Institute

Study Sponsor ^ICMJE

New York State Psychiatric Institute

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Jonathan W. Stewart, M.D.

New York State Psychiatric Institute - Columbia University Department of Psychiatry

Information Provided By

New York State Psychiatric Institute

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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