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



Status:Completed
Conditions:Anxiety, Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 50
Updated:4/2/2016
Start Date:April 2013
End Date:April 2015

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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.

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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from
Boston, MA
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