Treatment Of Patients With Social Anxiety Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Study CRH103390: A 12 Week Flexible Dose Study of GW876008, Placebo and Active Control (Paroxetine) in the Treatment of Social Anxiety Disorder (SocAD)

Conditions
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Social Phobia

Intervention / Treatment
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* Drug: GW876008
* Drug: paroxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW876008|nan|
|Drug: paroxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0) and Week 12 | 
| 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. | Baseline (Day 0) Week 12 | 
| 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. | Baseline (Day 0) and Week 12 | 
| 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. | Baseline (Day 0) and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 12 | 
| 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. | Baseline (Day 0) Up to Week 12 | 
| 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. | Baseline (Day 0) and up to Week 12 | 
| 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. | Up to Week 12 | 
| 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. | Up to Week 12 | 
| 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. | Up to 18 Weeks | 
| 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. | Up to Week 12 (pre dose) | 
| 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) | Up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, outpatients with a diagnosis of Social Anxiety disorder (SocAD)., effectiveness