Major Depressive DisorderPhase 2NCT01742832
Double-Blind Treatment of Major Depressive Disorder With Vilazodone
A Phase 2 study testing Vilazodone and Citalopram in people with Major Depressive Disorder, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vilazodone and Citalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women age 18-60;
- Primary diagnosis of MDD. Diagnosis of MDD will be made with the Structured Clinical Interview for DSM-IV
- Score of at least 23 on the Montgomery-Åsberg Depression Rating Scale
- Treatment with citalopram at a dose no higher than 20mg/day for no longer than 4 weeks (subjects not currently taking an antidepressant will be started on citalopram 20mg/day for the 6-week open-label phase)
- Ability to understand and sign the consent form.
Who cannot join
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (e.g., congestive heart failure, bradyarrhythmias).
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)
- Past 3-month DSM-IV substance abuse or dependence
- Illegal substance use based on urine toxicology screening
- Initiation of psychotherapy or behavior therapy specifically for MDD from a mental health professional within 3 months prior to study baseline
Show all 12Show fewer
- Initiation of any other psychotropic medication within 2 months prior to study inclusion
- Concomitant use of any antidepressant (except low dose doxepin, amitriptyline, trazodone when used PRN as a hypnotic).
- Concomitant use of medications that prolong the QT interval or are CYP2C19 inhibitors (e.g., cimetidine)
- Previous treatment with vilazodone
- Diagnosis of bipolar I or II disorder or any psychotic disorder (anxiety disorders will be allowed as long as MDD is considered the primary psychiatric disorder)
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI
The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and citalopram have been approved for the treatment of major depressive disorder. This research is being done because the researchers want to find out if vilazodone works in reducing the symptoms of depression significantly more than a generic SSRI.
Read the detailed description
The goal of the proposed study is to evaluate the efficacy and safety of switching to Vilazodone in patients with major depressive disorder (MDD) who are unresponsive to, only partially responsive to, or cannot tolerate a trial of the generic SSRI, citalopram (e.g., "partially responsive" means patients who report that their depressive symptoms have improved through the use of citalopram but that significant depressive symptoms persist; "cannot tolerate" refers to patient report of intolerable side effects that result in a desire to discontinue the medication). Seventy-two subjects with major depressive disorder who are still symptomatic or report intolerable side effects after a 6-week open-label trial of citalopram 20mg/day ( i.e. who are not classified as responders) will be randomized to receive a higher maximum dose of citalopram (40mg/day) or switch to vilazodone during the randomization phase of the trial for 6 weeks. The hypothesis to be tested is that vilazodone will result in greater rates of treatment response and be better tolerated compared to being titrated up to a higher maximum dose (40mg/day) of citalopram. The proposed study will provide needed data on the efficacy of switching antidepressants when individuals do not fully respond to previous treatment or have intolerable side effects with a generic SSRI.
- Conditions
- Major Depressive Disorder
- Being tested
- Vilazodone, Citalopram
- Keywords
- Vilazodone, Citalopram, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VilazodoneDrug
A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
CitalopramDrug
For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Vilazodone | Active comparator | A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day. Receives: Drug: Vilazodone |
| Citalopram | Placebo comparator | For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day. Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.
MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.
Measured: Baseline and final MADRS scores during the double-blind phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Grant, MD,JD,MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742832
- Sponsor's protocol ID
- 2012MDDVilaz
- Status last verified
- Feb 2023
- First submitted
- 3 Dec 2012
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grant JE, Redden SA, Leppink EW. Double-blind switch study of vilazodone in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2017 May;32(3):121-126. doi: 10.1097/YIC.0000000000000166.
PubMed 28177953
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI
- ClinicalTrials.gov ID
- NCT01742832
- Acronym / sponsor ID
- 2012MDDVilaz
- Conditions
- Major Depressive Disorder
- Keywords
- Vilazodone, Citalopram, Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 30 May 2017
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 evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and citalopram have been approved for the treatment of major depressive disorder. This research is being done because the researchers want to find out if vilazodone works in reducing the symptoms of depression significantly more than a generic SSRI.
Detailed description
The goal of the proposed study is to evaluate the efficacy and safety of switching to Vilazodone in patients with major depressive disorder (MDD) who are unresponsive to, only partially responsive to, or cannot tolerate a trial of the generic SSRI, citalopram (e.g., "partially responsive" means patients who report that their depressive symptoms have improved through the use of citalopram but that significant depressive symptoms persist; "cannot tolerate" refers to patient report of intolerable side effects that result in a desire to discontinue the medication). Seventy-two subjects with major depressive disorder who are still symptomatic or report intolerable side effects after a 6-week open-label trial of citalopram 20mg/day ( i.e. who are not classified as responders) will be randomized to receive a higher maximum dose of citalopram (40mg/day) or switch to vilazodone during the randomization phase of the trial for 6 weeks. The hypothesis to be tested is that vilazodone will result in greater rates of treatment response and be better tolerated compared to being titrated up to a higher maximum dose (40mg/day) of citalopram. The proposed study will provide needed data on the efficacy of switching antidepressants when individuals do not fully respond to previous treatment or have intolerable side effects with a generic SSRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vilazodone | Active comparator | Drug: VilazodoneA fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day. |
| Citalopram | Placebo comparator | Drug: CitalopramFor those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women age 18-60;
- Primary diagnosis of MDD. Diagnosis of MDD will be made with the Structured Clinical Interview for DSM-IV
- Score of at least 23 on the Montgomery-Åsberg Depression Rating Scale
- Treatment with citalopram at a dose no higher than 20mg/day for no longer than 4 weeks (subjects not currently taking an antidepressant will be started on citalopram 20mg/day for the 6-week open-label phase)
- Ability to understand and sign the consent form.
Key exclusion criteria (12 listed)
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (e.g., congestive heart failure, bradyarrhythmias).
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)
- Past 3-month DSM-IV substance abuse or dependence
- Illegal substance use based on urine toxicology screening
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 |
|---|---|---|
| VilazodoneA fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day. | Drug | Vilazodone |
| CitalopramFor those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day. | Drug | Citalopram |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline and final MADRS scores during the double-blind phase.
The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included. MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28177953Grant JE, Redden SA, Leppink EW. Double-blind switch study of vilazodone in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2017 May;32(3):121-126. doi: 10.1097/YIC.0000000000000166.
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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.
Jon Grant, MD,JD,MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vilazodone and Citalopram in people with Major Depressive Disorder, run by University of Chicago 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 23 Feb 2023. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Baseline and final MADRS scores during the double-blind phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742832, which also lists 1 linked publication.
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 23 Feb 2023.