Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram
Information source: Indiana University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Escitalopram (Drug); Escitalopram (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Amit Anand, M.D., Principal Investigator, Affiliation: Indiana University School of Medicine
Overall contact:
Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu
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
Clinical Details
Official title: fMRI and Genotype Markers of Antidepressant Side Effects and Response in Young Adults Compare to Older Adults
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: Primary efficacy measure would be Hamilton Depression Rating Scale
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 Escitalopram(trade name: Lexapro).
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ages 18-21 and Ages 25-40 years and able to give voluntary informed consent.
- Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode
using the Mini International Neuropsychiatric Interview (M. I.N. I.).
- 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:
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective
disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental
(including organic mood) disorder.
- 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.
- 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.
Locations and Contacts
Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu
Indiana University Adult Psychiatric Clinic, Indianapolis, Indiana 46202, United States; Recruiting
Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu
Amit Anand, M.D., Principal Investigator
Additional Information
Starting date: May 2008
Ending date: December 2012
Last updated: June 30, 2008
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