Vilazodone for Separation Anxiety Disorder

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01999920
• Collaborator: Forest Laboratories (Industry)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Separation Anxiety Disorder	Drug: Vilazodone; Drug: Placebo	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Vilazodone for Separation Anxiety Disorder
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vilazodone 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; 10mg to 40mg per day for 12 weeks; Other Names: Viibryd (brand name)
Placebo Comparator: Placebo Pill placebo.	Drug: Placebo; One to two pills per day for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression-Improvement Scale [Up to 12 weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score [Up to 12 weeks]

   This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).

2. Change From Baseline in Attachment Style Questionnaire Score [Up to 12 weeks]

   Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).

3. Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire [Up to 12 weeks]

   Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.

4. Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder [Baseline and week 12]

   The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16).

5. Change From Baseline on Adult Separation Anxiety - 27 Scale [Up to 12 weeks]

   Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Forest Laboratories

Investigators

• Principal Investigator: Franklin Schneier, MD, NYSPI

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 7, 2016
• Informed Consent Form - Sep 30, 2016
• Study Protocol - Oct 7, 2016

More Information

Publications

• 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.
• 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.
• 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.
• 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. Erratum In: N Engl J Med. 2013 Jan 31;368(5):490.
• 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.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01999920
• Other Study ID Numbers: #6856
• First Posted: Dec 3, 2013
• Last Update Posted: Mar 7, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New York State Psychiatric Institute: Adult separation anxiety disorder; ASAD
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Anxiety, Separation; Vilazodone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Period Title: Overall Study
STARTED	13	11
COMPLETED	7	9
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Vilazodone	Placebo	Total
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks	Total of all reporting groups
Overall Participants	13	11	24
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.3 (14.2)	32.9 (15.6)	35.2 (14.7)
Sex: Female, Male (Count of Participants)
Female	8 61.5%	8 72.7%	16 66.7%
Male	5 38.5%	3 27.3%	8 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 15.4%	0 0%	2 8.3%
Not Hispanic or Latino	11 84.6%	11 100%	22 91.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 18.2%	2 8.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 15.4%	4 36.4%	6 25%
White	9 69.2%	3 27.3%	12 50%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 15.4%	2 18.2%	4 16.7%
Hamilton Depression Rating Scale 17-item (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.5 (6.3)	9.3 (5.0)	10.5 (5.7)
Attachment Style Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Confidence	30.5 (5.3)	25.3 (9.3)	28.1 (7.7)
Discomfort with Closeness	38.2 (8.9)	46.9 (7.7)	42.2 (9.3)
Relationships as Secondary	17.4 (6.0)	19.0 (5.9)	18.1 (5.9)
Need for Approval	23.8 (4.6)	26.1 (8.8)	24.8 (6.8)
Preoccupation with Relationships	34.4 (5.1)	33.6 (6.3)	34.0 (5.6)
Quality of Life Enjoyment & Satisfaction Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	46.5 (12.1)	55.4 (22.2)	50.6 (17.7)
Structured Clinical Interview for Separation Anxiety Disorder (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	10.8 (2.6)	10.2 (2.5)	10.5 (2.5)
Adult Separation Anxiety - 27 Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.3 (15.1)	52.0 (13.6)	47.8 (14.7)

Outcome Measures

1. Primary Outcome

Title	Clinical Global Impression-Improvement Scale
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Count of Participants [Participants]	7 53.8%	4 36.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.064
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score
Description	This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Mean (Standard Deviation) [units on a scale]	3.7 (3.2)	8.4 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	5.50
	Confidence Interval	(2-Sided) 95%; -1.32 to 12.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.13
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Attachment Style Questionnaire Score
Description	Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Confidence	32.3 (7.3)	26.9 (10.3)
Discomfort with Closeness	35.6 (5.9)	42.3 (6.9)
Relationships as Secondary	16.3 (4.3)	20.7 (9.1)
Need for Approval	20.6 (3.2)	23.6 (8.0)
Preoccupation with Relationships	30.0 (6.0)	32.1 (7.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments	Confidence variable
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; -4.85 to 5.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.44
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments	Discomfort with Closeness variable
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; -8.21 to 10.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.41
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments	Relationships as Secondary variable
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	3.94
	Confidence Interval	(2-Sided) 95%; -4.12 to 12.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.79
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments	Need for Approval variable
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	-2.60
	Confidence Interval	(2-Sided) 95%; -5.79 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.49
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments	Preoccupation with Relationships variable
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; -5.30 to 6.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.82
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire
Description	Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Mean (Standard Deviation) [units on a scale]	68.9 (9.8)	47.8 (31.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	-19.91
	Confidence Interval	(2-Sided) 95%; -34.23 to -5.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.99
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder
Description	The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16).
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Mean (Standard Deviation) [units on a scale]	3.1 (2.4)	5.0 (3.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	3.29
	Confidence Interval	(2-Sided) 95%; 0.42 to 6.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.43
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline on Adult Separation Anxiety - 27 Scale
Description	Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vilazodone	Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks	Pill placebo. Placebo: One to two pills per day for 12 weeks
Measure Participants	13	11
Mean (Standard Deviation) [units on a scale]	14.4 (12.6)	40.6 (19.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vilazodone, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Standard error
	Estimated Value	21.38
	Confidence Interval	(2-Sided) 95%; 5.64 to 37.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.65
	Estimation Comments

Adverse Events

Time Frame	Baseline to week 12
Arm/Group Title	Vilazodone		Placebo
Arm/Group Description	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. Vilazodone: 10mg to 40mg per day for 12 weeks		Pill placebo. Placebo: One to two pills per day for 12 weeks
All Cause Mortality
	Vilazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Serious Adverse Events
	Vilazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Vilazodone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/13 (100%)		11/11 (100%)
Blood and lymphatic system disorders
Bruising Easily	0/13 (0%)		3/11 (27.3%)
Eye disorders
Blurry Vision	1/13 (7.7%)		5/11 (45.5%)
Gastrointestinal disorders
Heartburn	3/13 (23.1%)		1/11 (9.1%)
Nausea	4/13 (30.8%)		4/11 (36.4%)
Vomiting	0/13 (0%)		2/11 (18.2%)
Decreased Appetite	4/13 (30.8%)		2/11 (18.2%)
Increased Appetite	6/13 (46.2%)		5/11 (45.5%)
Dry Mouth	5/13 (38.5%)		3/11 (27.3%)
Constipation	1/13 (7.7%)		3/11 (27.3%)
Diarrhea/Gas	4/13 (30.8%)		2/11 (18.2%)
General disorders
Insomnia	5/13 (38.5%)		3/11 (27.3%)
Fatigue	3/13 (23.1%)		5/11 (45.5%)
Nervous system disorders
Headache	6/13 (46.2%)		3/11 (27.3%)
Restlessness	3/13 (23.1%)		3/11 (27.3%)
Tremor	1/13 (7.7%)		3/11 (27.3%)
Impaired Coordination	1/13 (7.7%)		3/11 (27.3%)
Somnolence	2/13 (15.4%)		6/11 (54.5%)
Lightheadedness	6/13 (46.2%)		6/11 (54.5%)
Forgetfulness	1/13 (7.7%)		2/11 (18.2%)
Impaired Concentration	5/13 (38.5%)		5/11 (45.5%)
Apathy	3/13 (23.1%)		3/11 (27.3%)
Nervousness	1/13 (7.7%)		4/11 (36.4%)
Reproductive system and breast disorders
Decreased Libido (men)	2/13 (15.4%)		0/11 (0%)
Decreased Libido (women)	1/13 (7.7%)		4/11 (36.4%)
Sexual Dysfunction (men)	2/13 (15.4%)		0/11 (0%)
Sexual Dysfunction (women)	4/13 (30.8%)		4/11 (36.4%)
Skin and subcutaneous tissue disorders
Excessive Sweating	2/13 (15.4%)		2/11 (18.2%)
Skin Problems	1/13 (7.7%)		2/11 (18.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.