Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram

fMRI and Genotype Markers of Antidepressant Side Effects and Response in Young Adults Compare to Older Adults

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

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: Escitalopram

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).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Adult Psychiatric Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18-50 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Depressed Subjects Age: 18 - 25 yrs; Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25	Drug: Escitalopram; 10 mg of Escitalopram by mouth once a day for 8 weeks; Other Names: Lexapro
Other: Depressed Subjects Age: 16 - 50 yrs; Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50	Drug: Escitalopram; 10 mg of Escitalopram by mouth once a day for 8 weeks; Other Names: Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17-item Hamilton Depression Rating Scale (HAM-D)	Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Collaborators: National Alliance for Research on Schizophrenia and Depression
• Investigators: Principal Investigator: Amit Anand, M.D., Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 1, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: fMRI; Escitalopram; Lexapro; pictures
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 0711-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No