Treatment Of Patients With Social Anxiety Disorder

NCT00397722 | Completed Phase 2

• 1 other identifier: CRH103390
• Study Type: interventional
• Target: 299
• Locations: 7 countries
• Sites: 33

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.

Conditions

Social Phobia

Keywords

safety; outpatients with a diagnosis of Social Anxiety disorder (SocAD).; effectiveness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization

  Up to Week 12

• Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)

  Baseline (Day 0) Up to Week 12

• Change from Randomization in vital signs : heart rate

  Baseline (Day 0) and up to Week 12

• Number of participants with chemistry data outside the normal range (Any time post-Randomization)

  Up to Week 12

• Number of participants with hematology data outside the normal range (Any time post-Randomization)

  Up to Week 12

Interventions

GW876008 DRUG

paroxetine DRUG

Also known as: GW876008

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (33)

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

Burbank, California, 91506, United States

Location

GSK Investigational Site

Temecula, California, 92591, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Smyrna, Georgia, 30080, United States

Location

GSK Investigational Site

Oakbrook Terrace, Illinois, 60181, United States

Location

GSK Investigational Site

Rockville, Maryland, 20852, United States

Location

GSK Investigational Site

Farmington Hills, Michigan, 48336, United States

Location

GSK Investigational Site

Nutley, New Jersey, 07110, United States

Location

GSK Investigational Site

New York, New York, 10024, United States

Location

GSK Investigational Site

Media, Pennsylvania, 19063, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6L 5X8, Canada

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 2H4, Canada

Location

GSK Investigational Site

Miramichi, New Brunswick, E1V 3G5, Canada

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GSK Investigational Site

Mississauga, Ontario, L5M 4N4, Canada

Location

GSK Investigational Site

Kuopio, 70110, Finland

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GSK Investigational Site

Rauma, 26100, Finland

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GSK Investigational Site

Turku, 20100, Finland

Location

GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

Location

GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

Location

GSK Investigational Site

Göttingen, Lower Saxony, 37075, Germany

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GSK Investigational Site

Westerstede, Lower Saxony, 26655, Germany

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GSK Investigational Site

Berlin, 10629, Germany

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GSK Investigational Site

Hamar, 2301, Norway

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GSK Investigational Site

Oslo, 0364, Norway

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GSK Investigational Site

Sandvika, 1338, Norway

Location

GSK Investigational Site

Tygerberg, Eastern Cape, 7505, South Africa

Location

GSK Investigational Site

Durban, 3630, South Africa

Location

GSK Investigational Site

Observatory ,Cape Town, 7925, South Africa

Location

GSK Investigational Site

Gothenburg, SE-416 85, Sweden

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GSK Investigational Site

Malmo, SE-211 52, Sweden

Location

GSK Investigational Site

Uppsala, SE-753 21, Sweden

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

GW 876008; Paroxetine

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: November 9, 2006
• Primary Completion: September 5, 2007
• Study Completion: September 5, 2007
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

CA (4); NO (3); DE (5); US (12); FI (3); SE (3); ZA (3)