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

NCT00707863 | Completed Phase 4 Results

• 1 other identifier: 0711-14
• Study Type: interventional
• Target: 17
• 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

Escitalopram; Lexapro; fMRI; pictures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Depressed Subjects Age: 18 - 25 yrs

OTHER

Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25

Drug: Escitalopram

Depressed Subjects Age: 16 - 50 yrs

OTHER

Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50

Drug: Escitalopram

Interventions

Escitalopram DRUG

10 mg of Escitalopram by mouth once a day for 8 weeks

Also known as: Lexapro

Depressed Subjects Age: 16 - 50 yrs; Depressed Subjects Age: 18 - 25 yrs

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).
• 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.
• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Indiana University Adult Psychiatric Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small number of subjects were studied

Results Point of Contact

• Title: Amit Anand MD
• Organization: Indiana Uiniveristy

aanand@iupui.edu

3172747422

Study Officials

• Amit Anand, M.D.

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 1, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)