Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone
Intervention description: All subjects will receive Vilazodone at 10, 20 or 40mg.
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Vilazodone

Summary:

      This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10
      mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from
      generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S.
      FDA for the treatment of major depressive disorder in adults. The purpose of this study is to
      evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability
      (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As
      vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent
      the recurrence of depression, for the purposes of this study it is considered
      investigational. The word "investigational" means that the study drug is still being tested
      in research studies and has not been approved for this use by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years inclusive

          2. DSM-IV Diagnosis of major depressive disorder

          3. If female, nonpregnant/nonlactating

          4. If a sexually active female of reproductive potential, must be using adequate
             contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)

          5. Inadequate response to antidepressants: having a score of ≥14 on the 17-item HAMD or a
             CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single
             antidepressant (defined as an 6-week trial of acceptable therapeutic dose [40 mg of
             fluoxetine, paroxetine 30 mg of citalopram, 20 mg of escitalopram, 37.5 mg of
             paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR)

          6. Lack of tolerability of antidepressants: Patient reports of side effects that are
             judged to be clinically meaningful by the investigator

          7. HAMD item 2 score ≥ 2 at screening

          8. Duration of current MDD ≥ 4 weeks and < 24 months

        Exclusion Criteria:

          1. Any Axis I disorder within previous six months of screening except Generalized Anxiety
             Disorder, Social Anxiety Disorder, Panic Disorder and Simple Phobias

          2. MDD with postpartum onset, psychotic features or seasonal features

          3. DSM-IV substance abuse or dependence in the previous 6 months

          4. Medically unstable as judged by study investigators on clinical and/or laboratory
             findings

          5. Lack of capacity to provide informed, written, consent to investigators

          6. Previous intolerance to vilazodone or current use of vilazodone at screening or within
             3 months of study entry

          7. Significant suicide risk as judged by the investigator based on information collected
             on the Columbia Suicide Severity Rating Scale (CSSRS)

          8. History of augmentation with atypical antipsychotics, lithium, T3 or another
             antidepressant within 3 months of screening

          9. Failure of ≥ 3 adequate trials of different antidepressants for the current episode of
             MDD

         10. Concomitant medications: All medications for pre existing medical conditions will be
             permitted to continue unchanged provided subjects are on a stable dose of at least 12
             weeks. Subjects on concomitant mood stabilizers or atypical antipsychotics will
             require a 2-week washout prior to screening visit. Subjects on a minimum of 3 month of
             stable dose of hypnotics (e.g. zolpidem 10 mg per day or benzodiazepine dose of ≤ 2 mg
             per day of lorazepam or trazodone ≤ 100 mg per day or quetiapine ≤ 100 mg per day)
             will be allowed to continue their hypnotic medication at the same dose. Quetiapine at
             doses ≤ 100 mg per day is appropriate only for hypnotic effects. Over the counter
             medications will be permitted if in the opinion of the investigator, they are not
             considered to have any significant impact on the study. Any medication that has the
             potential to cause a clinical significant drug interaction with vilazodone in the
             judgment of the investigator will require a washout.