Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

Generalized Anxiety Disorder Clinical Trial

Official title:

A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616655
• Other study ID #: 194-027
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2008
• Last updated: July 27, 2015
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Description:

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male and female subjects must be between 18 and 50 years of age

• Subjects must have GAD

• Subjects must be in otherwise good general health

Exclusion Criteria:

• Subject has a documented history of HIV, hepatitis B or hepatitis C.

• Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.

• Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.

• Subject has presence or history of antisocial personality or other severe disorder

• Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).

• Subject has history of seizures, including febrile seizures.

• Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.

• Subject is undergoing or has undergone electroconvulsive therapy.

• Subject is a current smoker or has smoked within the last 12 months.

• Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• eszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
• eszopiclone
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
• Placebo
Placebo total daily dose 0.9 mg

Locations

Country	Name	City	State
United States	Comprehensive NeuroScience, Inc.	Atlanta	Georgia
United States	Future Search Trials	Austin	Texas
United States	Pharasite Research, Inc.	Baltimore	Maryland
United States	North Coast Clinical Trials	Beachwood	Ohio
United States	Southwestern Research, Inc.	Beverly Hills	California
United States	Birmingham Psychiatry Pharaceutical Studies, Inc.	Birmingham	Alabama
United States	Horizon Medical Services	Bismarck	North Dakota
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Florida Clinical Research Center LLC	Bradenton	Florida
United States	Coastal Research Associates, Inc.	Braintree	Massachusetts
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Southwestern Research, Inc.	Burbank	California
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	University of Virginia, Center for Psychiatric Clinical Research	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Patient Priority Clinical Sties, LLC	Cincinnati	Ohio
United States	CRI Worldwide, LLC	Clementon	New Jersey
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Oregon Center for Clinical Investigations, Inc.	Eugene	Oregon
United States	University of CT Health Center	Farmington	Connecticut
United States	Comprehensive NeuroScience, Inc.	Fresh Meadows	New York
United States	Sarkis Clinical Trials	Gainsville	Florida
United States	California Clinical Trials Medical Group	Glendale	California
United States	California clinical Trials Medical Group	Glendale	California
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Carolos Guerra, Jr., M.D.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	North Star Mdical Research, LLC	Middleburg Heights	Ohio
United States	Fieve Clinica Services, Inc.	New York	New York
United States	Medical & Behavioral Health Research, P.C.	New York	New York
United States	Medical & Behavioral Health Research, PC	New York	New York
United States	Comprehensive Psychiatric Care, PC	Norwich	Connecticut
United States	Excell Research	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Vince and Associats Clinical Research	Overland Park	Kansas
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	California Clinical Trials Medical Group	Paramount	California
United States	Comprehensive NeuroScience, Inc.	Park Ridge	Illinois
United States	Southwestern Research, Inc.	Pasadena	California
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Glenwood Psychiatric Associates, P.L.L.C.	Raleigh	North Carolina
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	San Antonio Psychiatric Research Center	San Antonio	Texas
United States	California clinical Trials Medical Group	San Diego	California
United States	Carmen Research	Smyrna	Georgia
United States	Comprehensive NeuroScience, Inc.	St. Petersburg	Florida
United States	Stanford Universtiy Medical center	Stanford	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater	THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.	Baseline to Week 8	No
Secondary	Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)	The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.	Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)	No
Secondary	Change in Individual Item Scores on HAM-A	The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.	Baseline, Weeks 2, 4, 6, 8	No
Secondary	Change From Baseline in Clinician Global Impression of Severity (CGI-S)	The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, "Considering your total clinical experience with this particular population, how anxious is the subject at this time?" The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity.	Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)	No
Secondary	Clinical Global Impression- Improvement (CGI-I)	CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, "Compared to his/her condition at Visit 2, how much has he/she changed?" The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement.	Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)	No
Secondary	Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response	The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score.	Week 2, 4, 6, 8	No
Secondary	Hamilton Anxiety Scale (HAM-A) Remission	The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less.	Week 2, 4, 6, 8 based on last observation carried forward (LOCF)	No
Secondary	Change From Baseline on Quality of Life Enjoyment and Satifaction Questionnaire (Q-LES-Q) Short Form	The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.	Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)	No
Secondary	Change From Baseline Insomnia Severity Index (ISI) Total Score	The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.	Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)	No
Secondary	Change From Baseline Sheehan Disability Scale (SDS)	The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.	Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)	No
Secondary	Change From Baseline Epworth Sleepiness Scale (ESS)	ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.	Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)	No