Phase 2
N=456
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00616655 ↗Enrolled (actual)
456
Serious AEs
0.7%
Results posted
Aug 2015
Primary outcome: 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 — -10.0; -9.3; -9.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- eszopiclone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-10.0; -9.3; -9.5 | — |
| SECONDARY Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) |
24.2; 24.0; 24.0; -5.7; -4.8; -6.0 | — |
| SECONDARY Change in Individual Item Scores on HAM-A |
2.8; 2.8; 2.8; -0.6; -0.5; -0.6 | — |
| SECONDARY Change From Baseline in Clinician Global Impression of Severity (CGI-S) |
4.4; 4.3; 4.4; -0.6; -0.4; -0.7 | — |
| SECONDARY Clinical Global Impression- Improvement (CGI-I) |
3.2; 3.2; 3.1; 2.9; 2.9; 2.7 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response |
21; 16; 27; 39; 41; 49 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) Remission |
7; 2; 9; 11; 10; 24 | — |
| SECONDARY Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form |
52.4; 52.2; 52.0; 3.1; 2.1; 1.5 | — |
| SECONDARY Change From Baseline Insomnia Severity Index (ISI) Total Score |
14.6; 14.3; 14.1; -2.4; -1.5; -2.7 | — |
| SECONDARY Change From Baseline Sheehan Disability Scale (SDS) |
15.3; 14.0; 14.8; -2.5; -0.9; -2.7 | — |
| SECONDARY Change From Baseline Epworth Sleepiness Scale (ESS) |
7.4; 8.4; 8.5; -0.1; -0.5; -0.4 | — |
Summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00616655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.