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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00616655
First received: February 4, 2008
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: eszopiclone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) [ Time Frame: Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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 in Individual Item Scores on HAM-A [ Time Frame: Baseline, Weeks 2, 4, 6, 8 ] [ Designated as safety issue: No ]
    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 in Clinician Global Impression of Severity (CGI-S) [ Time Frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impression- Improvement (CGI-I) [ Time Frame: Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response [ Time Frame: Week 2, 4, 6, 8 ] [ Designated as safety issue: No ]
    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.

  • Hamilton Anxiety Scale (HAM-A) Remission [ Time Frame: Week 2, 4, 6, 8 based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline on Quality of Life Enjoyment and Satifaction Questionnaire (Q-LES-Q) Short Form [ Time Frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline Insomnia Severity Index (ISI) Total Score [ Time Frame: Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline Sheehan Disability Scale (SDS) [ Time Frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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 Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    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.


Enrollment: 456
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Drug: eszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Other Name: SEP-225441
Active Comparator: 2
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Drug: eszopiclone
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Other Name: SEP-225441
Placebo Comparator: 3
Placebo total daily dose 0.9 mg
Drug: Placebo
Placebo total daily dose 0.9 mg
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616655

  Show 57 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: CNS Medical Director Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00616655     History of Changes
Other Study ID Numbers: 194-027
Study First Received: February 4, 2008
Results First Received: June 2, 2015
Last Updated: July 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 30, 2015