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

Primary Purpose

Major Depression

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Escitalopram, Lexapro, fMRI, pictures

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Indiana University Adult Psychiatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Depressed Subjects Age: 18 - 25 yrs

Depressed Subjects Age: 16 - 50 yrs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00707863

First Posted

June 30, 2008

Last Updated

August 23, 2016

Sponsor

Indiana University School of Medicine

Collaborators

National Alliance for Research on Schizophrenia and Depression

1. Study Identification

Unique Protocol Identification Number

NCT00707863

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indiana University School of Medicine

Collaborators

National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee

5. Study Description

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

Keywords

Escitalopram, Lexapro, fMRI, pictures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depressed Subjects Age: 18 - 25 yrs

Arm Type

Other

Arm Description

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

Arm Title

Depressed Subjects Age: 16 - 50 yrs

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

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

Primary Outcome Measure Information:

Title

17-item Hamilton Depression Rating Scale (HAM-D)

Description

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.

Time Frame

Baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Anand, M.D.

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Adult Psychiatric Clinic

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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