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Treatment Of Patients With Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00397722
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Social Phobia Drug: GW876008 Drug: paroxetine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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)
Actual Study Start Date : November 9, 2006
Primary Completion Date : September 5, 2007
Study Completion Date : September 5, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: GW876008 Drug: paroxetine
    Other Name: GW876008

Outcome Measures

Primary Outcome Measures :
  1. Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12) [ Time Frame: Baseline (Day 0) and 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.

  2. Change from randomization on the LSAS Fear subscale score at Week 12 [ Time Frame: Baseline (Day 0) 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.

  3. Change from randomization on the LSAS Avoidance subscale score at Week 12 [ Time Frame: Baseline (Day 0) and 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.

  4. Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12 [ Time Frame: Baseline (Day 0) and 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 :
  1. Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization [ Time Frame: Up to Week 12 ]
    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.

  2. Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP) [ Time Frame: Baseline (Day 0) Up to Week 12 ]
    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.

  3. Change from Randomization in vital signs : heart rate [ Time Frame: Baseline (Day 0) and up to Week 12 ]
    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.

  4. Number of participants with chemistry data outside the normal range (Any time post-Randomization) [ Time Frame: Up to Week 12 ]
    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.

  5. Number of participants with hematology data outside the normal range (Any time post-Randomization) [ Time Frame: Up to Week 12 ]
    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.

  6. Number of participants with All adverse events (AE) and serious adverse events SAE) [ Time Frame: Up to 18 Weeks ]
    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.

  7. Trough Concentration (Ctrough) [ Time Frame: Up to Week 12 (pre dose) ]
    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.

  8. Exposure at steady state (AUC (0-τ)) [ Time Frame: Up to Week 12 ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397722


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00397722     History of Changes
Other Study ID Numbers: CRH103390
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by GlaxoSmithKline:
safety
outpatients with a diagnosis of Social Anxiety disorder (SocAD).
effectiveness

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors