Social PhobiaPhase 2NCT00397722
Treatment Of Patients With Social Anxiety Disorder
A Phase 2 study testing GW876008 and paroxetine in people with Social Phobia, run by GlaxoSmithKline at 33 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- GW876008 and paroxetine
- How many people
- 299 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 9 Nov 2006to 5 Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are diagnosed with generalized social anxiety disorder/social phobia.
Who cannot join
- have a diagnosis of major depressive disorder
- have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
United States12 sites
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Burbank, California, 91506
GSK Investigational Site
Farmington Hills, Michigan, 48336
GSK Investigational Site
Media, Pennsylvania, 19063
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
New York, New York, 10024
GSK Investigational Site
Nutley, New Jersey, 07110
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Smyrna, Georgia, 30080
GSK Investigational Site
Temecula, California, 92591
Germany5 sites
GSK Investigational Site
Achim, Lower Saxony, 28832
GSK Investigational Site
Berlin, 10629
GSK Investigational Site
Göttingen, Lower Saxony, 37075
GSK Investigational Site
Hüttenberg, Hesse, 35625
GSK Investigational Site
Westerstede, Lower Saxony, 26655
Canada4 sites
GSK Investigational Site
Edmonton, Alberta, T6L 5X8
GSK Investigational Site
Kelowna, British Columbia, V1Y 2H4
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5
GSK Investigational Site
Mississauga, Ontario, L5M 4N4
Finland3 sites
GSK Investigational Site
Kuopio, 70110
GSK Investigational Site
Rauma, 26100
GSK Investigational Site
Turku, 20100
Norway3 sites
GSK Investigational Site
Hamar, 2301
GSK Investigational Site
Oslo, 0364
GSK Investigational Site
Sandvika, 1338
South Africa3 sites
GSK Investigational Site
Durban, 3630
GSK Investigational Site
Observatory ,Cape Town, 7925
GSK Investigational Site
Tygerberg, Eastern Cape, 7505
Sweden3 sites
GSK Investigational Site
Gothenburg, SE-416 85
GSK Investigational Site
Malmö, SE-211 52
GSK Investigational Site
Uppsala, SE-753 21
About this study
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)
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
- Being tested
- GW876008, paroxetine
- Keywords
- safety, outpatients with a diagnosis of Social Anxiety disorder (SocAD)., effectiveness
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW876008Drug
paroxetineDrug
Also called GW876008
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Week 12
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study start9 Nov 2006
- Primary completion5 Sep 2007
- Study completion5 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397722
- Sponsor's protocol ID
- CRH103390
- Status last verified
- Jul 2017
- First submitted
- 8 Nov 2006
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00397722
- Acronym / sponsor ID
- CRH103390
- Conditions
- Social Phobia
- Keywords
- safety, outpatients with a diagnosis of Social Anxiety disorder (SocAD)., effectiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2006 (actual)
- Primary completion
- 5 Sep 2007 (actual)
- Study completion
- 5 Sep 2007 (actual)
- First posted
- 9 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- are diagnosed with generalized social anxiety disorder/social phobia.
Key exclusion criteria (2 listed)
- have a diagnosis of major depressive disorder
- have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW876008 | Drug | – |
| paroxetineAlso: GW876008 | Drug | – |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Number of participants with abnormal electrocardiogram (ECG) findings any time post randomization
Time frame: Up to Week 12
Change from Randomization in Vital Signs: systolic and diastolic blood pressure (SBP and DBP)
Time frame: Baseline (Day 0) Up to Week 12
Change from Randomization in vital signs : heart rate
Time frame: Baseline (Day 0) and up to Week 12
Number of participants with chemistry data outside the normal range (Any time post-Randomization)
Time frame: Up to Week 12
Number of participants with hematology data outside the normal range (Any time post-Randomization)
Time frame: Up to Week 12
Number of participants with All adverse events (AE) and serious adverse events SAE)
Time frame: Up to 18 Weeks
Trough Concentration (Ctrough)
Time frame: Up to Week 12 (pre dose)
Exposure at steady state (AUC (0-τ))
Time frame: Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW876008 and paroxetine in people with Social Phobia, run by GlaxoSmithKline at 33 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Canada, Finland, Norway and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.