Double-Blind Treatment of Major Depressive Disorder With Vilazodone

This study is currently recruiting participants.
Verified June 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01742832
First received: December 3, 2012
Last updated: September 4, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.
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.
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.

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
Criteria

Inclusion Criteria:

  1. Men and women age 18-60;
  2. Primary diagnosis of MDD. Diagnosis of MDD will be made with the Structured Clinical Interview for DSM-IV
  3. Score of at least 23 on the Montgomery-Åsberg Depression Rating Scale
  4. 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)
  5. Ability to understand and sign the consent form.

Exclusion Criteria:

  1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (e.g., congestive heart failure, bradyarrhythmias).
  2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)
  4. Past 3-month DSM-IV substance abuse or dependence
  5. Illegal substance use based on urine toxicology screening
  6. Initiation of psychotherapy or behavior therapy specifically for MDD from a mental health professional within 3 months prior to study baseline
  7. Initiation of any other psychotropic medication within 2 months prior to study inclusion
  8. Concomitant use of any antidepressant (except low dose doxepin, amitriptyline, trazodone when used PRN as a hypnotic).
  9. Concomitant use of medications that prolong the QT interval or are CYP2C19 inhibitors (e.g., cimetidine)
  10. Previous treatment with vilazodone
  11. 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)
  12. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742832

Contacts
Contact: Katherine Derbyshire 7737029066 kderbyshire@uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60615
Principal Investigator: Jon E Grant, MD, JD, MPH         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon Grant, MD,JD,MPH University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01742832     History of Changes
Other Study ID Numbers: 2012MDDVilaz
Study First Received: December 3, 2012
Last Updated: September 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 April 17, 2014