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A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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ClinicalTrials.gov Identifier: NCT00296699
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : January 15, 2008
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Atypical Depression Drug: Duloxetine Phase 4

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  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine



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


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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Jonathon W. Stewart, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296699     History of Changes
Other Study ID Numbers: IRB4943
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

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 Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents