Double-Blind Treatment of Major Depressive Disorder With Vilazodone
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

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 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.
    

Intervention name(s): Vilazodone; Citalopram
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Citalopram; Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vilazodone; Citalopram; Major Depressive Disorder