Vilazodone for Separation Anxiety Disorder
Condition: Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Anxiety, Separation
Intervention: Vilazodone; Placebo
Intervention description: 10mg to 40mg per day for 12 weeks; One to two pills per day for 12 weeks
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Adult separation anxiety disorder; ASAD

Summary:

      The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a
      receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week
      treatment course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary (most clinically significant) diagnosis of DSM5 ASAD

          -  Able to give consent, fluent in English

        Exclusion Criteria:

          -  Past or current DSM-IV diagnosis of any psychotic disorder; organic mental disorder or
             other cognitive disorder; bipolar disorder; or antisocial personality disorder.
             Current MDD of moderate or greater severity. Any other current primary Axis I
             disorder.

          -  Recent history (past 3 months) of substance or alcohol abuse or dependence (other than
             nicotine or caffeine)

          -  Suicidal ideation or behavior (in the past year) that poses a significant danger to
             the subject

          -  Medical illness that could significantly increase risk of vilazodone treatment or
             interfere with assessment of diagnosis or treatment response, including organic brain
             impairment from stroke, CNS tumor, or demyelinating disease; renal impairment;
             diabetes mellitus

          -  Current or past history of seizure disorder (except febrile seizure in childhood)

          -  History of non-response to ≥ 2 serotonergic reuptake inhibitor antidepressants (SSRIs
             and/or SNRIs) for the treatment of ASAD after adequate treatment trials (adequate
             treatment is defined as at least 8 weeks at an adequate dose[s] based on approved
             package insert recommendations)

          -  Currently taking medication which has been effective for patient's ASAD

          -  For patients taking any ineffective psychoactive drug or herbal remedy, inability to
             tolerate or unwillingness to accept a drug-free period prior to beginning the study of
             2 weeks or 5 half-lives (whichever is longer) before beginning study treatment, or
             ever having been treated with a depot antipsychotic. Fluoxetine washout period will be
             at least 5 weeks.

          -  Requiring concomitant treatment with any prohibited medications, supplements, or
             herbal remedies, except for zolpidem, or zolpidem extended release for insomnia, which
             may be continued provided the medication has been used in a consistent manner for 4
             weeks prior to randomization

          -  History of intolerance or hypersensitivity to vilazodone, SNRIs or SSRIs

          -  History of light therapy, electroconvulsive therapy, vagus nerve stimulation,
             transcranial magnetic stimulation, or any other experimental procedure for central
             nervous system disorders within 6 months of beginning this study

          -  Pregnancy, lactation; for women of childbearing potential, not using an effective
             birth control method (e.g., oral contraceptive or double barrier method) for the
             duration of the study

          -  Current formal psychotherapy initiated within 3 months of beginning this study. This
             includes: psychodynamic, cognitive-behavioral and interpersonal therapies