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

NCT00532480 | Completed Phase 4 Results

• 1 other identifier: 0607-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depression

Keywords

Depression; Duloxetine; fMRI; pictures

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (1)

Duolxetine

OTHER

Open-label duloxetine 30 - 60 mg oral administration

Drug: Duloxetine

Interventions

Duloxetine DRUG

60 mg capsules

Also known as: Cymbalta

Duolxetine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Indiana University Adult Psychiatric Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Amit Anand
• Organization: Indiana University

aanand@iupui.edu

317-944-7422

Study Officials

• Amit Anand, MD

  Indiana University Schoole of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 20, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)