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

This study is currently recruiting participants.

Verified by Indiana University, July 2009

First Received: June 30, 2008 Last Updated: July 31, 2009 History of Changes

Sponsor:	Indiana University School of Medicine
Collaborator:	National Alliance for Research on Schizophrenia and Depression
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00707863

Purpose

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

Condition	Intervention	Phase
Major Depression	Drug: Escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	fMRI and Genotype Markers of Antidepressant Side Effects and Response in Young Adults Compare to Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Primary efficacy measure would be Hamilton Depression Rating Scale [ Time Frame: Started May 2008 to December 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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
2 Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50	Drug: Escitalopram 10 mg of Escitalopram by mouth per day for 8 weeks

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707863

Contacts

Contact: Abi French, MS	317-274-0318	abdfrenc@iupui.edu
Contact: Amit Anand, M.D	317-274-7422

Locations

United States, Indiana
Indiana University Adult Psychiatric Clinic	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Abi French, MS 317-274-0318 abdfrenc@iupui.edu
Principal Investigator: Amit Anand, M.D.

Sponsors and Collaborators

Indiana University School of Medicine

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Amit Anand, M.D.

Indiana University School of Medicine

More Information

No publications provided

Responsible Party:	Indiana University, School of Medicine, Department of Psychiatry ( Amit Anand, M.D. )
Study ID Numbers:	0711-14
Study First Received:	June 30, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00707863 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Escitalopram
Lexapro
fMRI
pictures

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009