The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives

November 7, 2016 updated by: Michael Henry, Massachusetts General Hospital
The purpose of this study is to determine whether vilazodone is more effective than citalopram for the treatment of anxious depression. We will use neuroimaging to see whether there are changes in the brains of patients receiving the drug vilazodone that are different from those of citalopram. These changes may show that vilazodone affects the brain differently than most other kinds of standard antidepressant medications.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study proposes to utilize recent advances in magnetic resonance spectroscopy (MRS) techniques that permit reliable measurement of Glu in humans (9) to examine whether Vilazodone and citalopram exert differential effects on Glutamatergic neurotransmission in the ACC of anxious unipolar depressed patients. Functional connectivity as measured by Blood Oxygen Level Dependent (BOLD) MRI will be assessed to determine the relationship between the change in connectivity and the change in Glu levels with treatment. We also propose to examine, in an exploratory fashion, the relative effect of the two drugs on BOLD activation in the insula cortex.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, aged 18-50 years.
  • Meets DSM-IV criteria for unipolar major depression.
  • MADRS score > 20.
  • Subject exhibits clinically significant anxiety and HAM-A score > 15.
  • Capable of providing informed consent.
  • Has an established residence and phone.

Exclusion Criteria:

  • A clinically significant medical condition which could impact the response of the individual to antidepressant treatment (e.g. diabetes, cancer, lupus or other autoimmune illness). Stably treated hypothyroidism (TSH < 2) will be permitted.
  • Beta blockers, antidepressants, antipsychotics, lithium, antiepileptic medications, steroids (oral and inhaled), chronic use of nonsteroidal antinflamatory medications (infrequent sporadic use permitted), or other medications with the potential to interfere with the antidepressant effects of Vilazodone.
  • Pregnancy.
  • In women of childbearing potential an unwillingness to use reliable methods to prevent pregnancy.
  • History of manic or psychotic symptoms.
  • History of seizure or epilepsy.
  • History of alcohol or drug dependence and active use of substances in the past month.
  • Active alcohol or drug abuse.
  • Ingestion of 4 or more caffeinated beverages a day, on average.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vilazodone
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
Drug: Vilazodone
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
Other Names:
  • Viibryd
Active Comparator: Citalopram
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks.
Drug: Citalopram
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks
Other Names:
  • Celexa, Cipramil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glutamate Levels
Time Frame: Week 0 and Week 4
Our hypothesis that Vilazodone will increase ACC glutamate levels more than Citalopram will be addressed using a repeated measures linear regression model with ACC glutamate level as the outcome and drug (Vilazodone or Citalopram) and drug x scan time (baseline or follow-up) interaction as predictors.
Week 0 and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Connectivity
Time Frame: Week 0 and Week 4
Our hypothesis that Vilazodone will decrease functional connectivity more than Citalopram will be addressed using a repeated measures linear regression model with functional connectivity correlation as the outcome and drug (Vilazodone or Citalopram) and drug x scan time (baseline or follow-up) interaction as predictors.
Week 0 and Week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BOLD signal
Time Frame: Week 0 and Week 4
Exploratory analyses will estimate the effect size of the different treatments on change in BOLD signal.
Week 0 and Week 4
Change in MADRS Score
Time Frame: Screen and Weeks 0, 2, 4, 6, & 8
Associations with change in MADRS score will be quantified by incorporating treatment, change in glutamate level, change in functional connectivity, and their interactions with follow-up time as predictors in repeated measures linear regression models with MADRS scores as repeated outcomes.
Screen and Weeks 0, 2, 4, 6, & 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Michael E Henry, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VII-IT-10
  • 2013P000335 (Other Identifier: Partners Human Research Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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