Back to resultsTreatment Of Patients With Social Anxiety Disorder
Primary Purpose
Social Phobia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW876008
paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring safety, outpatients with a diagnosis of Social Anxiety disorder (SocAD)., effectiveness
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12)
The LSAS is an investigator-rated scale consisting of 48 questions concerning various social situations. The LSAS is the first psychiatric assessment at all post-screening visits. A qualified independent efficacy rater scored the participant's "fear or anxiety" and "avoidance" of social situations on 4-point scale : where, 0= None, 1= Mild, 2= Moderate, 3= Severe. Scores were recorded in participant's source documents. The LSAS total score was the sum of each of the forty-eight individual responses. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Change from randomization on the LSAS Fear subscale score at Week 12
The LSAS consisted of 24 fear responses. All individual items were rated on a scale 0 (none) -3 (severe) with higher scores indicating more severe fear. The LSAS fear subscale score was the sum of each of the 24 individual responses. If at least 22 items of the items making up the subscale of interest were present at a particular time point, the subscale score was calculated as Sum of non-missing items multiplied with 24/Number of non-missing items. If less than 22 of the items making up the score of interest were available for a participant at a particular time point, the subscale score was not calculated for that time point. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Change from randomization on the LSAS Avoidance subscale score at Week 12
The LSAS consisted of 24 avoidance responses. All individual items were rated on a scale 0 (never) -3 (always) with higher scores indicating more severe avoidance. The LSAS avoidance subscale Score was the sum of each of the 24 individual responses. If at least 22 items of the items making up the subscale of interest were present at a particular time point, the total score was calculated as Sum of non-missing items multiplied with 24/Number of non-missing items. If less than 22 of the items making up the score of interest were available for a participant at a particular time point, the subscale score was not calculated for that time point. . Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12
The SADS is a 28 item questionnaire. The total score was obtained by summing together the responses for all 28 items from the SADS questionnaire. Each individual item was rated as true or false. One point was given where items 2, 5, 8, 10, 11, 13, 14, 16, 18, 20, 21, 23, 24, 26 were marked as true and 1 point when each of the remaining items were marked as false. This gave a possible range of possible scores from 0 to 28 with higher scores indicating more severe disorder. If at least 26 of the items making up the total score were present at a particular time point, the total score was calculated as Sum of scores for non-missing items multiplied with 28/Number of non-missing items. If less than 26 of the items making up the score of interest were available for a participant at a particular time point, the total score was not calculated for that time point.
Secondary Outcome Measures
Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization
All 12-lead ECGs were digitally acquired by a qualified clinician and transmitted to a specified central laboratory. The ECG traces were interpreted by a qualified physician. Number of participants with abnormal ECG findings were reported.
Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)
Vital signs were measured at all scheduled study visits which included SBP and DBP. Change from Baseline values were presented for SBP and DBP. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from value at scheduled study visits. Data presented for maximum (max) increase-decrease in SBP/DBP.
Change from Randomization in vital signs : heart rate
Vital signs were measured at all scheduled study visits which included heart rate. Change from Baseline values were presented for heart rate. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from value at scheduled study visits. Data presented for max increase-decrease in heart rate.
Number of participants with chemistry data outside the normal range (Any time post-Randomization)
Number of participants with chemistry values outside the normal range up to 12 weeks were presented. Chemistry parameters included: Calcium, Bicarbonate, Chloride, Creatine Kinase, Creatinine, Magnesium, Phosphorus, Potassium, Sodium, Urea and Uric Acid.
Number of participants with hematology data outside the normal range (Any time post-Randomization)
Number of participants with hematology values outside the normal range up to 12 weeks were presented. Hematology parameters included: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), Monocytes, Platelet count, Red blood cell, Total neutrophils and White blood cells.
Number of participants with All adverse events (AE) and serious adverse events SAE)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Trough Concentration (Ctrough)
Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples for Pharmacokinetic assessment were collected pre dose at Week 1, Week 2, Week 4, Week 8 and Week 12.
Exposure at steady state (AUC (0-τ))
Blood samples for Pharmacokinetic assessment were collected pre dose at Week 1, Week 2, Week 4, Week 8 and Week 12. for AUC (0-τ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00397722
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2006 (Actual)
Primary Completion Date
September 5, 2007 (Actual)
Study Completion Date
September 5, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
safety, outpatients with a diagnosis of Social Anxiety disorder (SocAD)., effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW876008
Intervention Type
Drug
Intervention Name(s)
paroxetine
Other Intervention Name(s)
GW876008
Primary Outcome Measure Information:
Title
Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12)
Description
The LSAS is an investigator-rated scale consisting of 48 questions concerning various social situations. The LSAS is the first psychiatric assessment at all post-screening visits. A qualified independent efficacy rater scored the participant's "fear or anxiety" and "avoidance" of social situations on 4-point scale : where, 0= None, 1= Mild, 2= Moderate, 3= Severe. Scores were recorded in participant's source documents. The LSAS total score was the sum of each of the forty-eight individual responses. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Time Frame
Baseline (Day 0) and Week 12
Title
Change from randomization on the LSAS Fear subscale score at Week 12
Description
The LSAS consisted of 24 fear responses. All individual items were rated on a scale 0 (none) -3 (severe) with higher scores indicating more severe fear. The LSAS fear subscale score was the sum of each of the 24 individual responses. If at least 22 items of the items making up the subscale of interest were present at a particular time point, the subscale score was calculated as Sum of non-missing items multiplied with 24/Number of non-missing items. If less than 22 of the items making up the score of interest were available for a participant at a particular time point, the subscale score was not calculated for that time point. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Time Frame
Baseline (Day 0) Week 12
Title
Change from randomization on the LSAS Avoidance subscale score at Week 12
Description
The LSAS consisted of 24 avoidance responses. All individual items were rated on a scale 0 (never) -3 (always) with higher scores indicating more severe avoidance. The LSAS avoidance subscale Score was the sum of each of the 24 individual responses. If at least 22 items of the items making up the subscale of interest were present at a particular time point, the total score was calculated as Sum of non-missing items multiplied with 24/Number of non-missing items. If less than 22 of the items making up the score of interest were available for a participant at a particular time point, the subscale score was not calculated for that time point. . Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from Week 12 value. Data for adjusted mean and SE is presented.
Time Frame
Baseline (Day 0) and Week 12
Title
Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12
Description
The SADS is a 28 item questionnaire. The total score was obtained by summing together the responses for all 28 items from the SADS questionnaire. Each individual item was rated as true or false. One point was given where items 2, 5, 8, 10, 11, 13, 14, 16, 18, 20, 21, 23, 24, 26 were marked as true and 1 point when each of the remaining items were marked as false. This gave a possible range of possible scores from 0 to 28 with higher scores indicating more severe disorder. If at least 26 of the items making up the total score were present at a particular time point, the total score was calculated as Sum of scores for non-missing items multiplied with 28/Number of non-missing items. If less than 26 of the items making up the score of interest were available for a participant at a particular time point, the total score was not calculated for that time point.
Time Frame
Baseline (Day 0) and Week 12
Secondary Outcome Measure Information:
Title
Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization
Description
All 12-lead ECGs were digitally acquired by a qualified clinician and transmitted to a specified central laboratory. The ECG traces were interpreted by a qualified physician. Number of participants with abnormal ECG findings were reported.
Time Frame
Up to Week 12
Title
Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)
Description
Vital signs were measured at all scheduled study visits which included SBP and DBP. Change from Baseline values were presented for SBP and DBP. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from value at scheduled study visits. Data presented for maximum (max) increase-decrease in SBP/DBP.
Time Frame
Baseline (Day 0) Up to Week 12
Title
Change from Randomization in vital signs : heart rate
Description
Vital signs were measured at all scheduled study visits which included heart rate. Change from Baseline values were presented for heart rate. Day 0 was Baseline and change from Baseline was calculated by subtracting Baseline value from value at scheduled study visits. Data presented for max increase-decrease in heart rate.
Time Frame
Baseline (Day 0) and up to Week 12
Title
Number of participants with chemistry data outside the normal range (Any time post-Randomization)
Description
Number of participants with chemistry values outside the normal range up to 12 weeks were presented. Chemistry parameters included: Calcium, Bicarbonate, Chloride, Creatine Kinase, Creatinine, Magnesium, Phosphorus, Potassium, Sodium, Urea and Uric Acid.
Time Frame
Up to Week 12
Title
Number of participants with hematology data outside the normal range (Any time post-Randomization)
Description
Number of participants with hematology values outside the normal range up to 12 weeks were presented. Hematology parameters included: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), Monocytes, Platelet count, Red blood cell, Total neutrophils and White blood cells.
Time Frame
Up to Week 12
Title
Number of participants with All adverse events (AE) and serious adverse events SAE)
Description
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Time Frame
Up to 18 Weeks
Title
Trough Concentration (Ctrough)
Description
Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples for Pharmacokinetic assessment were collected pre dose at Week 1, Week 2, Week 4, Week 8 and Week 12.
Time Frame
Up to Week 12 (pre dose)
Title
Exposure at steady state (AUC (0-τ))
Description
Blood samples for Pharmacokinetic assessment were collected pre dose at Week 1, Week 2, Week 4, Week 8 and Week 12. for AUC (0-τ)
Time Frame
Up to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
GSK Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
GSK Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
GSK Investigational Site
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
GSK Investigational Site
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
07110
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
GSK Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
GSK Investigational Site
City
Miramichi
State/Province
New Brunswick
ZIP/Postal Code
E1V 3G5
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
GSK Investigational Site
City
Rauma
ZIP/Postal Code
26100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
GSK Investigational Site
City
Huettenberg
State/Province
Hessen
ZIP/Postal Code
35625
Country
Germany
Facility Name
GSK Investigational Site
City
Achim
State/Province
Niedersachsen
ZIP/Postal Code
28832
Country
Germany
Facility Name
GSK Investigational Site
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
GSK Investigational Site
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2301
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0364
Country
Norway
Facility Name
GSK Investigational Site
City
Sandvika
ZIP/Postal Code
1338
Country
Norway
Facility Name
GSK Investigational Site
City
Tygerberg
State/Province
Eastern Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
GSK Investigational Site
City
Durban
ZIP/Postal Code
3630
Country
South Africa
Facility Name
GSK Investigational Site
City
Observatory ,Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-211 52
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-753 21
Country
Sweden
12. IPD Sharing Statement
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Treatment Of Patients With Social Anxiety Disorder
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