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

NCT02028026 | Withdrawn Phase 4

• 2 other identifiers: VII-IT-102013P000335
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Anxiety; Comorbidity

Keywords

Depressive Disorder; Anxiety; Comorbidity; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Citalopram; Vilazodone; Serotonin Uptake Inhibitors; Receptor, Serotonin, 5-HT1A

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional Connectivity

  Week 0 and Week 4

Other Outcomes (2)

• Change in BOLD signal

  Week 0 and Week 4

• Change in MADRS Score

  Screen and Weeks 0, 2, 4, 6, & 8

Study Arms (2)

Vilazodone

EXPERIMENTAL

10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.

Drug: Vilazodone

Citalopram

ACTIVE COMPARATOR

20 mg/day for 2 weeks and then 40 mg/day for 6 weeks.

Drug: Citalopram

Interventions

Vilazodone DRUG

10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.

Also known as: Viibryd

Vilazodone

Citalopram DRUG

20 mg/day for 2 weeks and then 40 mg/day for 6 weeks

Also known as: Celexa, Cipramil

Citalopram

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Depressive Disorder

Interventions

Vilazodone Hydrochloride; Citalopram; Dexetimide

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Propylamines; Amines; Organic Chemicals; Nitriles; Piperidones; Piperidines

Study Officials

• Michael E Henry, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Bipolar Clinic

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

US (1)