Double-Blind Treatment of Major Depressive Disorder With Vilazodone
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone; Citalopram
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Vilazodone; Citalopram; Major Depressive Disorder

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.
    

Eligibility 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