Major Depressive DisorderPhase 4NCT02028026
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
A Phase 4 study testing Vilazodone and Citalopram in people with Major Depressive Disorder and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Major Depressive Disorder, Anxiety, Comorbidity
- What is being tested?
- Vilazodone and Citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Anxiety, Comorbidity
- Being tested
- Vilazodone, Citalopram
- Keywords
- Depressive Disorder, Anxiety, Comorbidity, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Citalopram, Vilazodone, Serotonin Uptake Inhibitors, Receptor, Serotonin, 5-HT1A
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VilazodoneDrug
Also called Viibryd
10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
CitalopramDrug
Also called Celexa, Cipramil
20 mg/day for 2 weeks and then 40 mg/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vilazodone | Experimental | 10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks. Receives: Drug: Vilazodone |
| Citalopram | Active comparator | 20 mg/day for 2 weeks and then 40 mg/day for 6 weeks. Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and Week 4
Secondary outcomes (1)
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.
Measured: Week 0 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionApr 2015
Why it stopped: Inability to recruit eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Henry, Massachusetts General Hospital
- Investigators
- Michael E Henry, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028026
- Sponsor's protocol ID
- VII-IT-10
- Other IDs
- 2013P000335
- Status last verified
- Nov 2016
- First submitted
- 3 Jan 2014
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives
- ClinicalTrials.gov ID
- NCT02028026
- Acronym / sponsor ID
- VII-IT-10
- Conditions
- Major Depressive Disorder, Anxiety, Comorbidity
- Keywords
- Depressive Disorder, Anxiety, Comorbidity, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Citalopram, Vilazodone, Serotonin Uptake Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit eligible subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vilazodone | Experimental | Drug: Vilazodone10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks. |
| Citalopram | Active comparator | Drug: Citalopram20 mg/day for 2 weeks and then 40 mg/day for 6 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VilazodoneAlso: Viibryd10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks. | Drug | Vilazodone |
| CitalopramAlso: Celexa, Cipramil20 mg/day for 2 weeks and then 40 mg/day for 6 weeks | Drug | Citalopram |
Primary outcome
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.
1 secondary outcome
Functional Connectivity
Time frame: Week 0 and Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Henry, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vilazodone and Citalopram in people with Major Depressive Disorder and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutamate Levels (time frame: Week 0 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.