Back to resultsThe Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
Primary Purpose
Major Depressive Disorder, Anxiety, Comorbidity
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vilazodone
Citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depressive Disorder, Anxiety, Comorbidity, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Citalopram, Vilazodone, Serotonin Uptake Inhibitors, Receptor, Serotonin, 5-HT1A
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vilazodone
Citalopram
Arm Description
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02028026
First Posted
January 3, 2014
Last Updated
November 7, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02028026
Brief Title
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
Official Title
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to recruit eligible subjects
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vilazodone
Arm Type
Experimental
Arm Description
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
Arm Title
Citalopram
Arm Type
Active Comparator
Arm Description
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa, Cipramil
Intervention Description
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks
Primary Outcome Measure Information:
Title
Glutamate Levels
Description
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.
Time Frame
Week 0 and Week 4
Secondary Outcome Measure Information:
Title
Functional Connectivity
Description
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.
Time Frame
Week 0 and Week 4
Other Pre-specified Outcome Measures:
Title
Change in BOLD signal
Description
Exploratory analyses will estimate the effect size of the different treatments on change in BOLD signal.
Time Frame
Week 0 and Week 4
Title
Change in MADRS Score
Description
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.
Time Frame
Screen and Weeks 0, 2, 4, 6, & 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Henry, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
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