Serotonin Transporter Genetic Variation and Amygdalar Activation Correlates of Antidepressant Response

NCT00456430 | Completed Phase 4

• 2 other identifiers: 0408-3441-869-41
• Study Type: interventional
• Target: 80
• 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.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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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

  Started: July 2003 ended August 2007

• Improvement in scores on Hamilton Depression Rating Scale

  Started July 2003 Ended August 2007

Secondary Outcomes (1)

• Improvement in scores on the Hamilton Anxiety Rating Scale

  Started July 2003 ended August 2007

Interventions

Escitalopram DRUG

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.

Also known as: lexapro

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-45 years and able to give voluntary informed consent.
• Satisfy criteria for Major Depression using the Structured Clinical Interview for DSM-IV (SCID-IV).
• item Hamilton Depression Rating Scale 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 5 point on either the HDRS during the course of the study.
• No danger to self or others.
• No psychotic symptoms.
• If genetically the patient is a match/meets our requirements for the study. The ratio of s genotype and the l/l genotype is 3:2. 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.
• 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.

You may not qualify if:

• 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.
• 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

Study Sites (1)

Indiana University Adult Psychiatry Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: April 5, 2007
• Study Start: July 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 15, 2011

Record last verified: 2010-01

Locations

US (1)