Clinical trial NCT02028026: 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
Overall status: WITHDRAWN
Phase: PHASE4
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Glutamate Levels
timeFrame: Week 0 and Week 4
Secondary outcomes:
measure: Functional Connectivity
timeFrame: Week 0 and Week 4
Other outcomes:
measure: Change in BOLD signal
timeFrame: Week 0 and Week 4
measure: Change in MADRS Score
timeFrame: Screen and Weeks 0, 2, 4, 6, & 8
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael E Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: