Last updated: 11/04/2018 09:41:57
A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Social Anxiety Disorder
Trial description: The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS) total score at the Week 12 last observation carried forward (LOCF).
Timeframe: Baseline (Week 0) and Week 12
Secondary outcomes:
Percentage of participants who scored 1 or 2 (very much improved or much improved) on the Clinical Global Impression Global Improvement (CGI-I) item at Week 12 LOCF
Timeframe: Week 12
Change from Baseline in the Clinical Global Impression Severity of Illness (CGI-S) item score at Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the LSAS Fear subscale score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the LSAS Avoidance subscale score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the Sheehan Disability Scale (SDS) total score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the SDS family life item at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the SDS work item at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the SDS social life item at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the Medical Outcomes Study (MOS) 12-item Sleep Module (sum of 9 items) at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the Leeds Sleep Evaluation Questionnaire (LSEQ) Getting to Sleep subscale score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the LSEQ Quality of Sleep subscale score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the LSEQ Awakening from Sleep subscale score at the Week 12 LOCF
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline on the LSEQ Behavior Following Wakefulness subscale score at the Week 12
Timeframe: Baseline (Week 0) and Week 12
Percentage of participants assessed for Satisfaction with Study Medication at the Week 12 LOCF
Timeframe: Week 12
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Upto Week 12
Number of participants with adverse events leading to study withdrawal
Timeframe: Upto Week 12
Number of participants with clinical chemistry data outside the reference range of potential clinical concern (PCC) any time on treatment (ATOT)
Timeframe: Upto Week 12
Number of participants with hematology data outside the reference range of PCC ATOT
Timeframe: Upto Week 12
Number of participants with vital signs data for systolic blood pressure, diastolic blood pressure, heart rate and body weight of PCC ATOT
Timeframe: Upto Week 12
Number of participants with abnormal urinalysis results confirmed by dipstick analysis
Timeframe: Upto Week 12
Number of participants with abnormal electrocardiogram (ECG) findings ATOT defined by clinical significance
Timeframe: Upto Week 12
Interventions:
Drug: Paroxetine 20-30 mg/Day
Drug: Casopitant 80-120 mg/Day
Drug: Casopitant 20-30 mg/Day
Drug: Placebo of Paroxetine 20-30 mg/Day
Drug: Placebo of Casopitant 80-120 mg/Day
Drug: Placebo of Casopitant 20-30 mg/Day
Enrollment:
238
Observational study model:
Not applicable
Primary completion date:
2006-28-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Anxiety Disorders
Product
casopitant, paroxetine
Collaborators
Not applicable
Study date(s)
August 2005 to September 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
- If female, must commit to consistent and correct use of an acceptable method of birth control.
- Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
- Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
- If female, must commit to consistent and correct use of an acceptable method of birth control.
Exclusion criteria:
- Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
- Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
- Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
- Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
- Patients with an unstable medical disorder.
- Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
- Patients who are taking other psychoactive medications.
Trial location(s)
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1122AAN
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19149
Status
Study Complete
Location
GSK Investigational Site
North Miami, Florida, United States, 33161
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91506
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580208
Status
Study Complete
Location
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Status
Study Complete
Location
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
Status
Study Complete
Location
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
Status
Study Complete
Location
GSK Investigational Site
La Plata/Buenos Aires, Buenos Aires, Argentina, B1896AEH
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-28-09
Actual study completion date
2006-28-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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