Treatment Of Patients With Social Anxiety Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Drug: paroxetine; Drug: GW876008

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6L 5X8
      • GSK Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • GSK Investigational Site
  • New Brunswick
    • Miramichi, New Brunswick, Canada, E1V 3G5
      • GSK Investigational Site
  • Ontario
    • Mississauga, Ontario, Canada, L5M 4N4
      • GSK Investigational Site
• Finland
  • Kuopio, Finland, 70110
    • GSK Investigational Site
  • Rauma, Finland, 26100
    • GSK Investigational Site
  • Turku, Finland, 20100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Hessen
    • Huettenberg, Hessen, Germany, 35625
      • GSK Investigational Site
  • Niedersachsen
    • Achim, Niedersachsen, Germany, 28832
      • GSK Investigational Site
    • Goettingen, Niedersachsen, Germany, 37075
      • GSK Investigational Site
    • Westerstede, Niedersachsen, Germany, 26655
      • GSK Investigational Site
• Norway
  • Hamar, Norway, 2301
    • GSK Investigational Site
  • Oslo, Norway, 0364
    • GSK Investigational Site
  • Sandvika, Norway, 1338
    • GSK Investigational Site
• South Africa
  • Durban, South Africa, 3630
    • GSK Investigational Site
  • Observatory ,Cape Town, South Africa, 7925
    • GSK Investigational Site
  • Eastern Cape
    • Tygerberg, Eastern Cape, South Africa, 7505
      • GSK Investigational Site
• Sweden
  • Göteborg, Sweden, SE-416 85
    • GSK Investigational Site
  • Malmö, Sweden, SE-211 52
    • GSK Investigational Site
  • Uppsala, Sweden, SE-753 21
    • GSK Investigational Site
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • GSK Investigational Site
    • Burbank, California, United States, 91506
      • GSK Investigational Site
    • Temecula, California, United States, 92591
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • GSK Investigational Site
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
      • GSK Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • GSK Investigational Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • GSK Investigational Site
  • New Jersey
    • Nutley, New Jersey, United States, 07110
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10024
      • GSK Investigational Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2006
• Primary Completion (Actual): September 5, 2007
• Study Completion (Actual): September 5, 2007

Study Registration Dates

• First Submitted: November 8, 2006
• First Submitted That Met QC Criteria: November 8, 2006
• First Posted (Estimate): November 9, 2006

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: safety; effectiveness; outpatients with a diagnosis of Social Anxiety disorder (SocAD).
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: CRH103390