Clinical trial NCT00397722: Treatment Of Patients With Social Anxiety Disorder
Official title: Study CRH103390: A 12 Week Flexible Dose Study of GW876008, Placebo and Active Control (Paroxetine) in the Treatment of Social Anxiety Disorder (SocAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Phobia
Keywords: safety
outpatients with a diagnosis of Social Anxiety disorder (SocAD).
effectiveness
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical and behavior symptoms that people with SocAD experience in social situations.


Eligibility criteria: Inclusion criteria:

* are diagnosed with generalized social anxiety disorder/social phobia.

Exclusion criteria:

* have a diagnosis of major depressive disorder
* have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.

Primary outcomes:
measure: Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12)
timeFrame: Baseline (Day 0) and Week 12
measure: Change from randomization on the LSAS Fear subscale score at Week 12
timeFrame: Baseline (Day 0) Week 12
measure: Change from randomization on the LSAS Avoidance subscale score at Week 12
timeFrame: Baseline (Day 0) and Week 12
measure: Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12
timeFrame: Baseline (Day 0) and Week 12
Secondary outcomes:
measure: Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization
timeFrame: Up to Week 12
measure: Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)
timeFrame: Baseline (Day 0) Up to Week 12
measure: Change from Randomization in vital signs : heart rate
timeFrame: Baseline (Day 0) and up to Week 12
measure: Number of participants with chemistry data outside the normal range (Any time post-Randomization)
timeFrame: Up to Week 12
measure: Number of participants with hematology data outside the normal range (Any time post-Randomization)
timeFrame: Up to Week 12
measure: Number of participants with All adverse events (AE) and serious adverse events SAE)
timeFrame: Up to 18 Weeks
measure: Trough Concentration (Ctrough)
timeFrame: Up to Week 12 (pre dose)
measure: Exposure at steady state (AUC (0-τ))
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Burbank
country: United States
facility: GSK Investigational Site
state: California
city: Temecula
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Smyrna
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oakbrook Terrace
country: United States
facility: GSK Investigational Site
state: Illinois
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Farmington Hills
country: United States
facility: GSK Investigational Site
state: Michigan
city: Nutley
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Media
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Miramichi
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Rauma
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Huettenberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Achim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Westerstede
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Sandvika
country: Norway
facility: GSK Investigational Site
city: Tygerberg
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Observatory ,Cape Town
country: South Africa
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: