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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00707863
First received: June 30, 2008
Last updated: March 5, 2013
Last verified: October 2011
  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 4

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

Resource links provided by NLM:


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 ]

Enrollment: 17
Study Start Date: May 2008
Study Completion Date: December 2012
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
Other Name: Lexapro
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
Other Name: Lexapro

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Indiana
Indiana University Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202
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 ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00707863     History of Changes
Other Study ID Numbers: 0711-14
Study First Received: June 30, 2008
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Escitalopram
Lexapro
fMRI
pictures

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014