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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02028026

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Anxiety Comorbidity	Drug: Vilazodone Drug: Citalopram	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Glutamate Levels [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.

Secondary Outcome Measures

Functional Connectivity [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.

Other Outcome Measures

Change in BOLD signal [Week 0 and Week 4]
Exploratory analyses will estimate the effect size of the different treatments on change in BOLD signal.
Change in MADRS Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.