- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296699
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
January 14, 2008 updated by: New York State Psychiatric Institute
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Study Overview
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
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Depression Evaluation Service - New York State Psychiatric Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Scale (HAM-D)
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory (BDI)
Time Frame: 10 weeks
|
10 weeks
|
Atypical Depression Diagnostic Scale (ADDS)
Time Frame: 10 weeks
|
10 weeks
|
Clinical Global Impression (CGI)
Time Frame: 10 weeks
|
10 weeks
|
Patient Global Impression (PGI)
Time Frame: 10 weeks
|
10 weeks
|
Inventory of Depressive Symptoms(IDS)
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jonathan W. Stewart, M.D., New York State Psychiatric Institute - Columbia University Department of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 23, 2006
First Submitted That Met QC Criteria
February 23, 2006
First Posted (Estimate)
February 27, 2006
Study Record Updates
Last Update Posted (Estimate)
January 15, 2008
Last Update Submitted That Met QC Criteria
January 14, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- IRB4943
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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