Treatment Of Patients With Social Anxiety Disorder

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00397722

Collaborator

(none)

299

Enrollment

Locations

9.9

Actual Duration (Months)

9.1

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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

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 :

Nov 9, 2006

Actual Primary Completion Date :

Sep 5, 2007

Actual Study Completion Date :

Sep 5, 2007

Outcome Measures

Primary Outcome Measures

Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12) [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.
Change from randomization on the LSAS Fear subscale score at Week 12 [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.
Change from randomization on the LSAS Avoidance subscale score at Week 12 [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.
Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12 [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

Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization [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.
Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP) [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.
Change from Randomization in vital signs : heart rate [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.
Number of participants with chemistry data outside the normal range (Any time post-Randomization) [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.
Number of participants with hematology data outside the normal range (Any time post-Randomization) [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.
Number of participants with All adverse events (AE) and serious adverse events SAE) [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.
Trough Concentration (Ctrough) [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.
Exposure at steady state (AUC (0-τ)) [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

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Beverly Hills	California	United States	90210
2	GSK Investigational Site	Burbank	California	United States	91506
3	GSK Investigational Site	Temecula	California	United States	92591
4	GSK Investigational Site	Miami	Florida	United States	33173
5	GSK Investigational Site	Orlando	Florida	United States	32806
6	GSK Investigational Site	Smyrna	Georgia	United States	30080
7	GSK Investigational Site	Oakbrook Terrace	Illinois	United States	60181
8	GSK Investigational Site	Rockville	Maryland	United States	20852
9	GSK Investigational Site	Farmington Hills	Michigan	United States	48336
10	GSK Investigational Site	Nutley	New Jersey	United States	07110
11	GSK Investigational Site	New York	New York	United States	10024
12	GSK Investigational Site	Media	Pennsylvania	United States	19063
13	GSK Investigational Site	Edmonton	Alberta	Canada	T6L 5X8
14	GSK Investigational Site	Kelowna	British Columbia	Canada	V1Y 2H4
15	GSK Investigational Site	Miramichi	New Brunswick	Canada	E1V 3G5
16	GSK Investigational Site	Mississauga	Ontario	Canada	L5M 4N4
17	GSK Investigational Site	Kuopio		Finland	70110
18	GSK Investigational Site	Rauma		Finland	26100
19	GSK Investigational Site	Turku		Finland	20100
20	GSK Investigational Site	Huettenberg	Hessen	Germany	35625
21	GSK Investigational Site	Achim	Niedersachsen	Germany	28832
22	GSK Investigational Site	Goettingen	Niedersachsen	Germany	37075
23	GSK Investigational Site	Westerstede	Niedersachsen	Germany	26655
24	GSK Investigational Site	Berlin		Germany	10629
25	GSK Investigational Site	Hamar		Norway	2301
26	GSK Investigational Site	Oslo		Norway	0364
27	GSK Investigational Site	Sandvika		Norway	1338
28	GSK Investigational Site	Tygerberg	Eastern Cape	South Africa	7505
29	GSK Investigational Site	Durban		South Africa	3630
30	GSK Investigational Site	Observatory ,Cape Town		South Africa	7925
31	GSK Investigational Site	Göteborg		Sweden	SE-416 85
32	GSK Investigational Site	Malmö		Sweden	SE-211 52
33	GSK Investigational Site	Uppsala		Sweden	SE-753 21