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

NCT ID: NCT02028026

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder Anxiety Comorbidity

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vilazodone

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

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

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

Citalopram

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

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

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

Interventions

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Vilazodone

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

Intervention Type DRUG

Citalopram

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

Intervention Type DRUG

Other Intervention Names

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Viibryd Celexa, Cipramil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Henry

Medical Director, Bipolar Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael E Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2013P000335

Identifier Type: OTHER

Identifier Source: secondary_id

VII-IT-10

Identifier Type: -

Identifier Source: org_study_id