CompletedNCT00707863Updated Oct 17, 2016Results posted

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

A Phase 4 interventional study of Escitalopram in Major Depression, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by Indiana University School of Medicine · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 17
Allocation: Non-randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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

Read the 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).

Conditions studied

Major Depression

Browse trials for

Depressive Disorder, Major 2,741

Keywords

Escitalopram
Lexapro
fMRI
pictures

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's enrollment of 17 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 17 participants (actual)

Study arms

Other
Depressed Subjects Age: 18 - 25 yrs
Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25
Drug: Escitalopram
Other
Depressed Subjects Age: 16 - 50 yrs
Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Drug: Escitalopram

Interventions

DrugEscitalopram
10 mg of Escitalopram by mouth once a day for 8 weeks
Also known as: Lexapro

What researchers measure

Primary outcomes

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.
Time frame: Baseline and 8 weeks

Results

Posted Oct 17, 2016

Limitations and caveats

Small number of subjects were studied

Participant flow

Participant flow — Overall Study
Milestone	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs
Started	6	11
Completed	6	8
Not completed	0	3

Outcome measures

Primary17-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.

Time frame:: Baseline and 8 weeks
Reported as:: Mean · units on a scale

17-item Hamilton Depression Rating Scale (HAM-D)
units on a scale	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs
Baseline 17-item HAM-D	18 ± 1	19 ± 1
Post-8 week treatment 17-item HAM-D	6 ± 3	6 ± 4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Subjects Age: 18 - 25	—	0/6 (0%)	5/6 (83.3%)
Subjects Age: 26 - 50	—	0/11 (0%)	11/11 (100%)

Most frequent other events

Showing 10 of 26

Most frequent other events
Event	Subjects Age: 18 - 25	Subjects Age: 26 - 50
Decreased appetiteGastrointestinal disorders	4/6	5/11
Increased sleepNervous system disorders	4/6	5/11
Dry mouthGastrointestinal disorders	1/6	7/11
Decreased sleepNervous system disorders	2/6	6/11
DrowsinessNervous system disorders	3/6	5/11
HeadacheNervous system disorders	3/6	5/11
SweatingSkin and subcutaneous tissue disorders	1/6	5/11
DizzinessNervous system disorders	2/6	4/11
decreased libidoReproductive system and breast disorders	2/6	4/11
ConstipationGastrointestinal disorders	0/6	4/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs	Total
<=18 years	0	0	0
Between 18 and 65 years	6	11	17
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs	Total
Mean	22 ± 1	34 ± 6	30 ± 7

Sex: Female, Male
Sex: Female, Male(Participants)	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs	Total
Female	5	9	14
Male	1	2	3

Region of Enrollment
Region of Enrollment(participants)	Depressed Subjects Age: 18 - 25 Yrs	Depressed Subjects Age: 16 - 50 Yrs	Total
United States	6	11	17

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00707863
Lead sponsor: Indiana University School of Medicine
Collaborators: National Alliance for Research on Schizophrenia and Depression
Responsible party: Sponsor
First posted: Jul 1, 2008
Start date: May 2008
Primary completion: Dec 2012
Completion: Dec 2012
Results posted: Oct 17, 2016
Last update: Oct 17, 2016

Study contacts

Amit Anand, M.D.

principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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