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

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ClinicalTrials.gov Identifier: NCT02028026
Recruitment Status : Withdrawn (Inability to recruit eligible subjects)
First Posted : January 6, 2014
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Henry, Massachusetts General Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: Celexa, Cipramil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028026


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Michael E Henry, MD Massachusetts General Hospital

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Responsible Party: Michael Henry, Medical Director, Bipolar Clinic, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02028026     History of Changes
Other Study ID Numbers: VII-IT-10
2013P000335 ( Other Identifier: Partners Human Research Office )
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Michael Henry, Massachusetts General Hospital:
Depressive Disorder
Anxiety
Comorbidity
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Citalopram
Vilazodone
Serotonin Uptake Inhibitors
Receptor, Serotonin, 5-HT1A

Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin 5-HT1 Receptor Agonists
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vilazodone Hydrochloride
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents