Vilazodone for Separation Anxiety Disorder

NCT01999920 | Completed Phase 4 Results

• 1 other identifier: #6856
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Separation Anxiety Disorder

Keywords

Adult separation anxiety disorder; ASAD

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement Scale

  Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.

  Up to 12 weeks

Secondary Outcomes (5)

• Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score

  Up to 12 weeks

• Change From Baseline in Attachment Style Questionnaire Score

  Up to 12 weeks

• Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire

  Up to 12 weeks

• Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder

  Baseline and week 12

• Change From Baseline on Adult Separation Anxiety - 27 Scale

  Up to 12 weeks

Study Arms (2)

Vilazodone

EXPERIMENTAL

Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.

Drug: Vilazodone

Placebo

PLACEBO COMPARATOR

Pill placebo.

Drug: Placebo

Interventions

Vilazodone DRUG

10mg to 40mg per day for 12 weeks

Also known as: Viibryd (brand name)

Vilazodone

Placebo DRUG

One to two pills per day for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current primary (most clinically significant) diagnosis of DSM5 ASAD
• Able to give consent, fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Forest Laboratories: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (6)

• Shear K, Jin R, Ruscio AM, Walters EE, Kessler RC. Prevalence and correlates of estimated DSM-IV child and adult separation anxiety disorder in the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Jun;163(6):1074-83. doi: 10.1176/ajp.2006.163.6.1074.

  PMID: 16741209 BACKGROUND

• Winslow JT, Insel TR. Serotonergic modulation of the rat pup ultrasonic isolation call: studies with 5HT1 and 5HT2 subtype-selective agonists and antagonists. Psychopharmacology (Berl). 1991;105(4):513-20. doi: 10.1007/BF02244372.

  PMID: 1771219 BACKGROUND

• Simpson BS, Landsberg GM, Reisner IR, Ciribassi JJ, Horwitz D, Houpt KA, Kroll TL, Luescher A, Moffat KS, Douglass G, Robertson-Plouch C, Veenhuizen MF, Zimmerman A, Clark TP. Effects of reconcile (fluoxetine) chewable tablets plus behavior management for canine separation anxiety. Vet Ther. 2007 Spring;8(1):18-31.

  PMID: 17447222 BACKGROUND

• Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.

  PMID: 18974308 BACKGROUND

• Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703.

  PMID: 11323729 BACKGROUND

• Schneier FR, Moskow DM, Choo TH, Galfalvy H, Campeas R, Sanchez-Lacay A. A randomized controlled pilot trial of vilazodone for adult separation anxiety disorder. Depress Anxiety. 2017 Dec;34(12):1085-1095. doi: 10.1002/da.22693. Epub 2017 Oct 25.

  PMID: 29071764 DERIVED

MeSH Terms

Conditions

Anxiety, Separation

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Results Point of Contact

• Title: Franklin Schneier, MD
• Organization: NYSPI

fschneier@nyspi.columbia.edu

6464774-8041

Study Officials

• Franklin Schneier, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: December 30, 2017
• Last Updated: March 7, 2018
• Results First Posted: October 31, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)