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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02028026
• Other study ID #: VII-IT-10
• Secondary ID: 2013P000335
• Status: Withdrawn
• Phase: Phase 4
• First received: January 3, 2014
• Last updated: November 7, 2016
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Comorbidity
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vilazodone
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
• Citalopram
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in BOLD signal	Exploratory analyses will estimate the effect size of the different treatments on change in BOLD signal.	Week 0 and Week 4	No
Other	Change in MADRS Score	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	No
Primary	Glutamate Levels	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	No
Secondary	Functional Connectivity	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	No