Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01844115
• Collaborator: (none)
• Enrollment: 415
• Locations: 36
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site: 11.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder	Drug: Placebo; Drug: Vilazodone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 415 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
• Actual Study Start Date: Apr 30, 2013
• Actual Primary Completion Date: Mar 31, 2014
• Actual Study Completion Date: Mar 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Dose-matched placebo tablets, oral administration	Drug: Placebo; Other Names: Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.
Experimental: Vilazodone Vilazodone tablets, oral administration	Drug: Vilazodone; Viibryd; Other Names: Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [Baseline to Week 8]

   The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.

Secondary Outcome Measures

1. Change From Baseline in the Sheehan Disability Scale (SDS) Total Score [Baseline to Week 8]

   The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female outpatient, 18-70 years of age

• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder

• Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

• Women who are pregnant or who will be breastfeeding during the study

• Patients with a history of:

1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode

2. Any depressive episode with psychotic or catatonic features

3. Panic disorder with or without agoraphobia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Forest Investigative Site 023	Birmingham	Alabama	United States	35216
2	Forest Investigative Site 013	Phoenix	Arizona	United States	85032
3	Forest Investigative Site 036	Beverly Hills	California	United States	90210
4	Forest Investigative Site 001	Costa Mesa	California	United States	92626
5	Forest Investigative Site 009	Oceanside	California	United States	92056
6	Forest Investigative Site 026	Rancho Mirage	California	United States	92270
7	Forest Investigative Site 017	Sherman Oaks	California	United States	91403
8	Forest Investigative Site 034	Sherman Oaks	California	United States	91403
9	Forest Investigative Site 030	Bradenton	Florida	United States	34201
10	Forest Investigative Site 029	Gainesville	Florida	United States	32607
11	Forest Investigative Site 035	Jacksonville	Florida	United States	32256
12	Forest Investigative Site 032	Orlando	Florida	United States	32806
13	Forest Investigative Site 021	West Palm Beach	Florida	United States	33407
14	Forest Investigative Site 025	Atlanta	Georgia	United States	30328
15	Forest Investigative Site 018	Decatur	Georgia	United States	30030
16	Forest Investigative Site 022	Hoffman Estates	Illinois	United States	60169
17	Forest Investigative Site 014	Berlin	New Jersey	United States	08009
18	Forest Investigative Site 005	Cherry Hill	New Jersey	United States	08002
19	Forest Investigative Site 015	Albuquerque	New Mexico	United States	87109
20	Forest Investigative Site 027	Bronx	New York	United States	10467
21	Forest Investigative Site 028	Brooklyn	New York	United States	11214
22	Forest Investigative Site 010	Brooklyn	New York	United States	11235
23	Forest Investigative Site 002	Cedarhurst	New York	United States	11516
24	Forest Investigative Site 004	Mount Kisco	New York	United States	10549
25	Forest Investigative Site 003	New York	New York	United States	10003
26	Forest Investigative Site 007	New York	New York	United States	10021
27	Forest Investigative Site 020	New York	New York	United States	10168
28	Forest Investigative Site 019	Dayton	Ohio	United States	45417
29	Forest Investigative Site 008	Portland	Oregon	United States	97210
30	Forest Investigative Site 037	Allentown	Pennsylvania	United States	18104
31	Forest Investigative Site 011	Media	Pennsylvania	United States	19063
32	Forest Investigative Site 033	Memphis	Tennessee	United States	38119
33	Forest Investigative Site 031	Dallas	Texas	United States	75231
34	Forest Investigative Site 012	Herndon	Virginia	United States	20170
35	Forest Investigative Site 016	Bellevue	Washington	United States	98007
36	Forest Investigative Site 024	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Forest Laboratories

Investigators

• Study Director: Giovanna Forero, MA, Forest Research Institute, a subsidiary of Actavis plc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT01844115
• Other Study ID Numbers: VLZ-MD-07
• First Posted: May 1, 2013
• Last Update Posted: Dec 18, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Forest Laboratories: Generalized Anxiety Disorder, GAD
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Vilazodone Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Placebo	Vilazodone
Arm/Group Description	Dose-matched placebo tablets, oral administration	Vilazodone tablets, oral administration
Period Title: Overall Study
STARTED	202	202
COMPLETED	163	144
NOT COMPLETED	39	58

Baseline Characteristics

Arm/Group Title	Placebo	Vilazodone	Total
Arm/Group Description	Dose-matched placebo tablets, oral administration	Vilazodone tablets, oral administration	Total of all reporting groups
Overall Participants	202	202	404
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	40.7 (13.4)	39.2 (12.8)	39.9 (13.1)
Age, Customized (Number) [Number]
< 20	4 2%	2 1%	6 1.5%
20-29	53 26.2%	56 27.7%	109 27%
30-39	42 20.8%	55 27.2%	97 24%
40-49	46 22.8%	42 20.8%	88 21.8%
50-59	36 17.8%	26 12.9%	62 15.3%
≥ 60	21 10.4%	21 10.4%	42 10.4%
Sex/Gender, Customized (Number) [Number]
Male	65 32.2%	75 37.1%	140 34.7%
Female	137 67.8%	127 62.9%	264 65.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	25 12.4%	22 10.9%	47 11.6%
Not Hispanic or Latino	177 87.6%	180 89.1%	357 88.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Number) [Number]
White	153 75.7%	158 78.2%	311 77%
Black or African American	38 18.8%	33 16.3%	71 17.6%
Asian	5 2.5%	4 2%	9 2.2%
American Indian or Alaska Native	1 0.5%	1 0.5%	2 0.5%
Other	5 2.5%	6 3%	11 2.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.

Arm/Group Title	Placebo	Vilazodone
Arm/Group Description	Dose-matched placebo tablets, oral administration	Vilazodone tablets, oral administration
Measure Participants	200	200
Mean (Standard Deviation) [Score on Scale]	14.7 (7.41)	11.3 (6.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilazodone
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0048
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.20
	Confidence Interval	(2-Sided) 95%; -3.72 to -0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Description	The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.

Arm/Group Title	Placebo	Vilazodone
Arm/Group Description	Dose-matched placebo tablets, oral administration	Vilazodone tablets, oral administration
Measure Participants	200	200
Mean (Standard Deviation) [Score on scale]	9.2 (6.96)	7.4 (6.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilazodone
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0236
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.89
	Confidence Interval	(2-Sided) 95%; -3.52 to -0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events were collected until week 8.
Adverse Event Reporting Description	The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
Arm/Group Title	Placebo		Vilazodone
Arm/Group Description	Dose-matched placebo tablets, oral administration		Vilazodone tablets, oral administration
All Cause Mortality
	Placebo		Vilazodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/202 (0%)		0/202 (0%)
Serious Adverse Events
	Placebo		Vilazodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/202 (0%)		3/202 (1.5%)
Gastrointestinal disorders
Impaired gastric emptying	0/202 (0%)		1/202 (0.5%)
Infections and infestations
Urinary tract infection,	0/202 (0%)		1/202 (0.5%)
Injury, poisoning and procedural complications
Laceration	0/202 (0%)		1/202 (0.5%)
Stab wound	0/202 (0%)		1/202 (0.5%)
Other (Not Including Serious) Adverse Events
	Placebo		Vilazodone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/202 (40.1%)		115/202 (56.9%)
Gastrointestinal disorders
Nausea	26/202 (12.9%)		60/202 (29.7%)
Diarrhoea	12/202 (5.9%)		56/202 (27.7%)
Dry mouth	12/202 (5.9%)		12/202 (5.9%)
Infections and infestations
Upper respiratory tract infection	11/202 (5.4%)		5/202 (2.5%)
Nervous system disorders
Dizziness	8/202 (4%)		22/202 (10.9%)
Headache	36/202 (17.8%)		22/202 (10.9%)
Somnolence	6/202 (3%)		12/202 (5.9%)
Psychiatric disorders
Insomnia	8/202 (4%)		15/202 (7.4%)
Reproductive system and breast disorders
Ejaculation delayed +	1/65 (1.5%)		4/75 (5.3%)
Erectile dysfunction +	1/65 (1.5%)		4/75 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the investigator will be subject to mutual agreement between the investigator and Forest Research Institute, Inc.