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Completed

NCT Number: NCT00296699

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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

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Key information

Conditions

Atypical Depression Depressive Disorder Depressive Disorder, Major Dysthymic Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Depression Evaluation Service - New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

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 names: Cymbalta

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 10 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2005
Primary completion
2007
First posted
Feb 27, 2006
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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