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Completed

NCT Number: NCT00532480

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Adult Psychiatric Clinic

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Duloxetine

Drug

60 mg capsules

Other names: Cymbalta

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Duloxetine Effects on Brain fMRI Response to Emotionally Valenced Pictures in the Treatment of Patients With Major Depression

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2007
Registry last updated
Oct 3, 2016

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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