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DepressionPhase 4NCT00456430

Serotonin Transporter Genetic Variation and Amygdalar Activation Correlates of Antidepressant Response

A Phase 4 study testing Escitalopram in people with Depression, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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.In particular, this study will investigate whether variation in the serotonin transporter gene can affect the… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
Escitalopram
Type of treatment
Pill or oral medicine
How many people
80 participants
Where
1 siteUnited States
Study dates
Jul 2003to Aug 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-60 years and able to give voluntary informed consent.
  • No history of psychiatric illness or substance abuse or dependence as assessed by SCID for non-patients (SCID-NP).
  • No significant family history of psychiatric or neurological illness.
  • Not currently taking any prescription or centrally acting medications.
  • No serious medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.
  • If genetically the subject is a match/meets our requirements for the study. The ratio of s genotype and the l/l genotype is 4:1. Therefore, at some stage in the study we may have more of one type of genotype and may not be able to include a patient for whose genotype we already have sufficient number of subjects.

Who cannot join

  • Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
  • Use of neuroleptic 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Adult Psychiatry Clinic

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.In particular, this study will investigate whether variation in the serotonin transporter gene can affect the response to escitalopram as measured by clinical interview and MRI scan. We will measure activity in different parts of the brain, while subjects see pictures, using Magnetic Resonance Imaging (MRI) scan. There will be three MRI scans; one before we start any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment. Treatment will consist of Escitalopram. Additionally a blood sample will be taken for genetic testing. 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

Hypotheses:

Hypothesis 1: Depressed patients with the s/s or s/L alleles of the 5-HTTLPR polymorphism will have greater amygdalar activation and decreased cortico-amygdala connectivity compared to patients with L/L genotype

Hypothesis 2: After 2 and 8 weeks of treatment with escitalopram (10 mg) depressed patients with the L/L allele will have a greater decrease in amygdalar activation and a greater increase in cortico-amygdala connectivity than patients with s/s or s/L genotypes.

Methods:

We will stratify the subjects in the two genotype groups so that they are comparable in terms of age and gender distributions. Only depressed patients will be treated with escitalopram. Healthy subjects and unmedicated currently euthymic depressed patients will have baseline scan and subsequent repeat fMRI scans at the same intervals as the depressed patients but will not receive any treatment. After completing the first fMRI scan, depressed patients will undergto one week of single blind placebo lead in. After the first week patient's depression symptoms will be assessed again. If depression symptoms are much better after the first week ( > 20% reduction in HAM-D scores) then the patient will not be asked to do the rest of the study and will be referred to a clinician of their choice for further treatment as necessary. If their depression symptoms do not show much improvement after the first week then they will be asked to take escitalopram for the next 8 weeks. At the end of 3 weeks of treatment from baseline, the patient will undergo a second fMRI scan. Following the second fMRI scan the patient will be continued on escitalopram for another 6 weeks.

Conditions
Depression
Being tested
Escitalopram
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EscitalopramDrug

    Also called lexapro

    10 mg a day of escitalopram by mouth per day for 4 weeks. Dose may be increased to 20 mg a day after the 4th week depending on tolerance and treatment response.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in amygdalar activation and increase in cortico-amygdala connectivity as shown by fMRI given at baseline and three weeks from baseline and nine weeks from baseline

    Measured: Started: July 2003 ended August 2007

  2. Improvement in scores on Hamilton Depression Rating Scale

    Measured: Started July 2003 Ended August 2007

Secondary outcomes (1)

  1. Improvement in scores on the Hamilton Anxiety Rating Scale

    Measured: Started July 2003 ended August 2007

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2007 (estimated)
  2. Study startJul 2003
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00456430
Sponsor's protocol ID
0408-34
Other IDs
41-869-41
Status last verified
Jan 2010
First submitted
14 Sep 2005
Last updated
15 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram in people with Depression, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in amygdalar activation and increase in cortico-amygdala connectivity as shown by fMRI given at baseline and three weeks from baseline and nine weeks from baseline (time frame: Started: July 2003 ended August 2007). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.

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