Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532480
Recruitment Status : Completed
First Posted : September 20, 2007
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Eli Lilly and Company
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Brief Summary:
The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

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

Detailed Description:
This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called duloxetine.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duloxetine Effects on Brain fMRI Response to Emotionally Valenced Pictures in the Treatment of Patients With Major Depression
Study Start Date : September 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Open-label duloxetine 30 - 60 mg oral administration
Drug: Duloxetine
60 mg capsules
Other Name: Cymbalta

Primary Outcome Measures :
  1. 17-item Hamilton Depression Rating Scale [ Time Frame: 8 weeks ]
    Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria for Depressed Patients:

  • Ages 18 - 60 years and able to give voluntary informed consent.
  • Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode using the Structured Clinical Interview for DSM-IV (SCID-IV).
  • 17-item Hamilton Depression Rating Scale (HDRS) score > 18.
  • Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
  • Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:

    • Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
    • No danger to self or others.

Exclusion criteria for patients:

  • Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
  • Known hypersensitivity to duloxetine or any of the inactive ingredients.
  • On monoamine oxidase inhibitors in the past 2 weeks.
  • History of narrow angle glaucoma
  • Lack of response of the current episode of depression to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
  • Use of neuroleptic in the past 2 weeks.
  • Use of antidepressants in the past 2 weeks. If on fluoxetine in the past, then should not have been on this medication for 4 weeks.
  • History of lack of response to duloxetine.
  • Use of mood stabilizers in the past 2 weeks.
  • Use of benzodiazepines in the past 2 weeks.
  • Acutely suicidal or homicidal or requiring inpatient treatment.
  • Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
  • Use of alcohol in the past 1 week.
  • No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
  • Current pregnancy or breast-feeding.
  • Metallic implants.
  • Previously known positive HIV blood test as reported by the subject.

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 identifier (NCT number): NCT00532480

United States, Indiana
Indiana University Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Eli Lilly and Company
Principal Investigator: Amit Anand, MD Indiana University Schoole of Medicine

Responsible Party: Indiana University School of Medicine Identifier: NCT00532480     History of Changes
Other Study ID Numbers: 0607-22
First Posted: September 20, 2007    Key Record Dates
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Indiana University ( Indiana University School of Medicine ):

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
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
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents