Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
- Registration Number
- NCT00616655
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo total daily dose 0.9 mg 1 eszopiclone SEP-225441 (eszopiclone) total daily dose of 1.5 mg 2 eszopiclone SEP-225441 (eszopiclone) total daily dose of 0.9 mg
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater Baseline to Week 8 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinician Global Impression of Severity (CGI-S) Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) 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.
Hamilton Anxiety Scale (HAM-A) Remission Week 2, 4, 6, 8 based on last observation carried forward (LOCF) 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.
The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.Change in Individual Item Scores on HAM-A Baseline, Weeks 2, 4, 6, 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 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.
Change From Baseline Sheehan Disability Scale (SDS) Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) 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.
Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF) 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.
Change From Baseline Epworth Sleepiness Scale (ESS) Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) 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.
Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response Week 2, 4, 6, 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 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.
The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) 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.
Clinical Global Impression- Improvement (CGI-I) Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF) 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.
Change From Baseline Insomnia Severity Index (ISI) Total Score Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF) 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.
Trial Locations
- Locations (44)
Southwestern Research, Inc.
🇺🇸Pasadena, California, United States
Excell Research
🇺🇸Oceanside, California, United States
California Clinical Trials Medical Group
🇺🇸Paramount, California, United States
Stanford Universtiy Medical center
🇺🇸Stanford, California, United States
University of CT Health Center
🇺🇸Farmington, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainsville, Florida, United States
Florida Clinical Research Center LLC
🇺🇸Bradenton, Florida, United States
Comprehensive NeuroScience, Inc.
🇺🇸Fresh Meadows, New York, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Carmen Research
🇺🇸Smyrna, Georgia, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Pharasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Coastal Research Associates, Inc.
🇺🇸Braintree, Massachusetts, United States
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Fieve Clinica Services, Inc.
🇺🇸New York, New York, United States
Medical & Behavioral Health Research, PC
🇺🇸New York, New York, United States
Medical & Behavioral Health Research, P.C.
🇺🇸New York, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Glenwood Psychiatric Associates, P.L.L.C.
🇺🇸Raleigh, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
North Star Mdical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Future Search Trials
🇺🇸Austin, Texas, United States
University of Virginia, Center for Psychiatric Clinical Research
🇺🇸Charlottesville, Virginia, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Horizon Medical Services
🇺🇸Bismarck, North Dakota, United States
Clinical Trials Technology, Inc.
🇺🇸Prairie Village, Kansas, United States
Birmingham Psychiatry Pharaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States
California clinical Trials Medical Group
🇺🇸San Diego, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Patient Priority Clinical Sties, LLC
🇺🇸Cincinnati, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Carolos Guerra, Jr., M.D.
🇺🇸Houston, Texas, United States
San Antonio Psychiatric Research Center
🇺🇸San Antonio, Texas, United States
Vince and Associats Clinical Research
🇺🇸Overland Park, Kansas, United States
Comprehensive Psychiatric Care, PC
🇺🇸Norwich, Connecticut, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
North Coast Clinical Trials
🇺🇸Beachwood, Ohio, United States