This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

This study has been completed.
Eli Lilly and Company
Information provided by:
New York State Psychiatric Institute Identifier:
First received: February 23, 2006
Last updated: January 14, 2008
Last verified: January 2008
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.

Condition Intervention Phase
Atypical Depression Drug: Duloxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ]

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

Enrollment: 20
Study Start Date: March 2005
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00296699

United States, New York
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Eli Lilly and Company
Principal Investigator: Jonathan W. Stewart, M.D. New York State Psychiatric Institute - Columbia University Department of Psychiatry
  More Information

Additional Information:
Responsible Party: Jonathon W. Stewart, New York State Psychiatric Institute Identifier: NCT00296699     History of Changes
Other Study ID Numbers: IRB4943
Study First Received: February 23, 2006
Last Updated: January 14, 2008

Keywords provided by New York State Psychiatric Institute:
Atypical Depression
Major Depressive Disorder
Dysthymic Disorder
Atypical Features

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on August 18, 2017