A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression - Full Text View

Sponsors and Collaborators:	New York State Psychiatric Institute Eli Lilly and Company
Information provided by:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00296699

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 IV

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

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:

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.

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

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

Responsible Party:	New York State Psychiatric Institute ( Jonathon W. Stewart )
Study ID Numbers:	IRB4943
Study First Received:	February 23, 2006
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00296699
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

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood Disorders
Dysthymic Disorder

Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009