Duloxetine Hydrochloride and Duloxetine in Atypical Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Atypical Depression

Intervention / Treatment

Drug: Duloxetine

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

Interventional

Enrollment (Actual)

20

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10032
    - Depression Evaluation Service - New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory (BDI) Time Frame: 10 weeks	10 weeks
Atypical Depression Diagnostic Scale (ADDS) Time Frame: 10 weeks	10 weeks
Clinical Global Impression (CGI) Time Frame: 10 weeks	10 weeks
Patient Global Impression (PGI) Time Frame: 10 weeks	10 weeks
Inventory of Depressive Symptoms(IDS) Time Frame: 10 weeks	10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

Eli Lilly and Company

Investigators

Principal Investigator: Jonathan W. Stewart, M.D., New York State Psychiatric Institute - Columbia University Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria