Vilazodone for Separation Anxiety Disorder

In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation
Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be
randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo.
Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse
events and safety.

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