Double-Blind Treatment of Major Depressive Disorder With Vilazodone
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Vilazodone Drug: Citalopram |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Once during the 11 visits for the 18 week study ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vilazodone
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.
|
Drug: Vilazodone
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.
|
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Placebo Comparator: Citalopram
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.
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Drug: Citalopram
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Contacts and Locations| Contact: Katherine Derbyshire | 7737029066 | kderbyshire@uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60615 | |
| Principal Investigator: Jon E Grant, MD, JD, MPH | |
| Principal Investigator: | Jon Grant, MD,JD,MPH | University of Chicago |
More Information
No publications provided
| Responsible Party: | Jon Grant, Professor of Psychiatry, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01742832 History of Changes |
| Other Study ID Numbers: | 2012MDDVilaz |
| Study First Received: | December 3, 2012 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Vilazodone Citalopram Major Depressive Disorder |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on June 13, 2013