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

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Depression, Duloxetine, fMRI, pictures

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University Adult Psychiatric Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Duolxetine

Arm Description

Open-label duloxetine 30 - 60 mg oral administration

Outcomes

Primary Outcome Measures

17-item Hamilton Depression Rating Scale
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2007
Last Updated
August 8, 2016
Sponsor
Indiana University School of Medicine
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00532480
Brief Title
Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine
Official Title
Duloxetine Effects on Brain fMRI Response to Emotionally Valenced Pictures in the Treatment of Patients With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Depression, Duloxetine, fMRI, pictures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duolxetine
Arm Type
Other
Arm Description
Open-label duloxetine 30 - 60 mg oral administration
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
60 mg capsules
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Anand, MD
Organizational Affiliation
Indiana University Schoole of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Adult Psychiatric Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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