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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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296699

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

Additional Information:
Depression Evaluation Service - official website  This link exits the ClinicalTrials.gov site
New York State Psychiatric Institute - official website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonathon W. Stewart, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296699     History of Changes
Other Study ID Numbers: IRB4943
Study First Received: February 23, 2006
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013