Social PhobiaPhase 1NCT00555139

A Study To Compare The Putative Anxiolytic Effect Of 2 New Drugs In Subjects With Social Anxiety Disorder

A Phase 1 study testing GSK561679 tablet, GW876008 tablet and alprazolam in people with Social Phobia, run by GlaxoSmithKline at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo 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?: GSK561679 tablet, GW876008 tablet and alprazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 8 sitesSpain
Study dates: 27 Mar 2007to 10 Jan 2008
Phase: Phase 1
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

Outpatient with a primary diagnosis of Social Anxiety
LSAS score of 50 or more.
Men or women who are between 18 and 64 years of age. Women will be included in this study only if the reproductive toxicology data available at the time of study start will allow their inclusion, in accordance with regulatory requirements.
Body weight > 50 kg and BMI within the range 18.5 - 31.0 kg/m2.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
The subject must be able to read, comprehend and record information.

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A signed and dated written informed consent is obtained from the subject.
Subjects willing to restrict alcohol intake to 4 unit of alcohol or less per day. A unit is equivalent to 300 ml of beer or one measure of spirits or one glass of wine.
Women must be of non child bearing potential or commit to consistent and correct use of an acceptable method of birth control that must be recorded on the source documentation at screening and verified for continued compliance at each visit; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
Subjects with a history of peptic ulcer disease (PUD) with a known aetiology must provide documentation by a gastroenterologist of the aetiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms.

Who cannot join

Any concomitant drug dosing 24 h before each dosing.
Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of GW876008, GSK561679 or alprazolam, may pose a safety concern, or interfere with accurate assessment of safety.
The subject has a current or recent (within six months) documented gastrointestinal disease
Subject has symptoms of the presenting illness which are better accounted for by another diagnosis or subjects who meet DSM-IV criteria for any other Axis I disorder as a primary diagnosis currently or within 6 months prior to the screening visit or A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest nonresponsiveness to pharmacotherapy or non-compliance with the protocol; or A current (or within six months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or Subjects with a history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
HAMD-17 score greater than 15.

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Subjects who are currently receiving regularly scheduled psychotherapy (individual or group, including cognitive behavioural therapy), plan to initiate psychotherapy during the trial or have received regularly scheduled psychotherapy during the 12 week period prior to the Screening Visit.
Subjects have any laboratory abnormality that in the investigator's judgment is considered to be clinically significant and not resolved by the Randomization Visit.
The subject has a semi-supine systolic blood pressure less than 90mmHg (85mmHg for females) or greater than 140mmHg or a semi-supine diastolic blood pressure of less than 45mmHg or greater than 90mmHg; or a pulse rate less than 40bpm or more than 90bpm.
Women who have a positive serum Human Chorionic Gonadotropin (HCG) pregnancy test at screen visit, a positive urine dipstick test at Randomization, or who are lactating or planning to become pregnant within the next 2weeks after the Follow Up Visit.
The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
Exposure to more than four new chemical within 12 months prior to the first dosing day.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study.
History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (e.g., illiteracy, planned vacations, or planned hospitalizations during the study).
Subjects who are not euthyroid as evidenced by normal TSH. Subjects maintained with thyroid medication must be euthyroid for a period of at least six months prior to the screen visit.
Subject's level of FSH falling outside normal range
Subjects with diabetes or high risk of diabetes based on a documented history of impaired glucose tolerance.
Subjects have any electrocardiographic (ECG) parameter outside of the Sponsor-specified ranges at either screen or randomization visit.
Subjects who have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation within the 6 months prior to the Screening Visit.
Subjects, who are left-handed.
The subject has a positive pre-study urine drug/ breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Documented history of hepato-biliary disease or abnormality in hepatic enzymesat screening

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Spain8 sites

GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, E-08003
GSK Investigational Site
Barcelona
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Mataro (Barcelona)
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Terrassa - Barcelona, 08227

Other trials in Spain

About this study

Official title: Double-blind, Randomized, Placebo and Alprazolam-controlled Three-period Crossover Incomplete Block Design Study to Compare Putative Anxiolytic-like fRMI Activity of GW876008 and GSK561679 After Single-dose Administration in Subjects With Social Anxiety Disorder (SAD)

To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo

Conditions: Social Phobia
Being tested: GSK561679 tablet, GW876008 tablet, alprazolam, Placebo
Keywords: anxiety,, depression,, fMRI, CRF-1 antagonists,
Medical subject headings: Phobia, Social, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK561679 tabletDrug
GSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A.
GW876008 tabletDrug
GW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base).
alprazolamDrug
Also called GSK561679, GW876008
Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).
PlaceboDrug
GW876008 placebo tablets will visually match the active GW876008 tablets. GSK561679 placebo tablets will visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that will visually match the active but containing only a filler.

Study groups in NCT00555139
Study group	Role	What they receive
GW876008	Experimental	The subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam. Receives: Drug: GW876008 tablet; Drug: alprazolam; Drug: Placebo
GSK561679	Experimental	The subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam. Receives: Drug: GSK561679 tablet; Drug: alprazolam; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes of fMRI activation in amygdala of subjects with SAD during an emotional task after having received different compounds. Change in the VAS score in response to Public Speaking stress after having received different compounds.
Measured: over 6 weeks

Secondary outcomes (10)

Changes of fMRI activation patterns in all brain areas in subjects with SAD during an emotional task or resting state. Changes of cortisol levels and other stress indicators in response to Public Speaking stress.
Measured: over 6 weeks
Pk samples:
Measured: 2 hours,4-5, 8hours post-dose (over 3 weeks, week 1,2&3)
Cortisol, ACTH:
Measured: 5hours 20min,5hours 35 min, 6hours & 7hours post dose (over 6 weeks, week 1,2,3 &6)
Indicators of physiological state during the fMRI session:
Measured: pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6)
Heart rate (HR), Respiratory rate (RR), ventilation (pneumatic pletismography), and carbon dioxide percutaneous measurements monitored during the whole procedure (control and exploratory profile tests).
Measured: pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6)
Visual Analog Scale (VAS) measurements of distress
Measured: 3.5-4hours, 4.5-5.3hours, 5hours 20mins, 5hours 35mins, 5hours 43mins after public speaking, 6hours, 6hours 20mins, 7hours (week 1,2, and 3)
Maddox wing test.
Measured: Week 1, 2 and 3
questionnaire for sédation.
Measured: Week 1, 2 and 3
plasma levels of the various compounds to derive pharmacokinetic parameters
Measured: 1hour, 2hours, 4-5hours, 8hours (week 1, 2 and 3)
Safety and tolerability will be evaluated by adverse event monitoring, physical examination, ECG, vital signs and laboratory parameters
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 200710 Jan 2008

First posted7 Nov 2007 (estimated)
Study start27 Mar 2007
Primary completion10 Jan 2008
Study completion10 Jan 2008

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00555139
Sponsor's protocol ID: CRH108571
Status last verified: Aug 2017
First submitted: 5 Nov 2007
Last updated: 4 Aug 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Phobia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomized, Placebo and Alprazolam-controlled Three-period Crossover Incomplete Block Design Study to Compare Putative Anxiolytic-like fRMI Activity of GW876008 and GSK561679 After Single-dose Administration in Subjects With Social Anxiety Disorder (SAD)
ClinicalTrials.gov ID: NCT00555139
Acronym / sponsor ID: CRH108571
Conditions: Social Phobia
Keywords: anxiety,, depression,, fMRI, CRF-1 antagonists,
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Mar 2007 (actual)
Primary completion: 10 Jan 2008 (actual)
Study completion: 10 Jan 2008 (actual)
First posted: 7 Nov 2007 (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.

To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Number of arms: 2

Arm	Type	Receives
GW876008	Experimental	Drug: GW876008 tablet, Drug: alprazolam, Drug: PlaceboThe subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam.
GSK561679	Experimental	Drug: GSK561679 tablet, Drug: alprazolam, Drug: PlaceboThe subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Outpatient with a primary diagnosis of Social Anxiety
LSAS score of 50 or more.
Men or women who are between 18 and 64 years of age. Women will be included in this study only if the reproductive toxicology data available at the time of study start will allow their inclusion, in accordance with regulatory requirements.
Body weight > 50 kg and BMI within the range 18.5 - 31.0 kg/m2.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Key exclusion criteria (26 listed)

Any concomitant drug dosing 24 h before each dosing.
Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of GW876008, GSK561679 or alprazolam, may pose a safety concern, or interfere with accurate assessment of safety.
The subject has a current or recent (within six months) documented gastrointestinal disease
Subject has symptoms of the presenting illness which are better accounted for by another diagnosis or subjects who meet DSM-IV criteria for any other Axis I disorder as a primary diagnosis currently or within 6 months prior to the screening visit or A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest nonresponsiveness to pharmacotherapy or non-compliance with the protocol; or A current (or within six months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or Subjects with a history of Schizophrenia, Schizoaffective Disorder, or a 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
GSK561679 tabletGSK561679 tablets are white film-coated tablets, containing 200 (milligrams) mg of the free base, GSK561679A.	Drug	GSK561679
GW876008 tabletGW876008 tablets are white to off-white round film-coated tablets, containing 100 mg of GW876008X (free base).	Drug	GW876008
alprazolamAlso: GSK561679, GW876008Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).	Drug	GSK561679, GW876008
PlaceboGW876008 placebo tablets will visually match the active GW876008 tablets. GSK561679 placebo tablets will visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that will visually match the active but containing only a filler.	Drug	GSK561679, GW876008

Primary outcome

Changes of fMRI activation in amygdala of subjects with SAD during an emotional task after having received different compounds. Change in the VAS score in response to Public Speaking stress after having received different compounds.
Time frame: over 6 weeks

10 secondary outcomes

Changes of fMRI activation patterns in all brain areas in subjects with SAD during an emotional task or resting state. Changes of cortisol levels and other stress indicators in response to Public Speaking stress.
Time frame: over 6 weeks
Pk samples:
Time frame: 2 hours,4-5, 8hours post-dose (over 3 weeks, week 1,2&3)
Cortisol, ACTH:
Time frame: 5hours 20min,5hours 35 min, 6hours & 7hours post dose (over 6 weeks, week 1,2,3 &6)
Indicators of physiological state during the fMRI session:
Time frame: pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6)
Heart rate (HR), Respiratory rate (RR), ventilation (pneumatic pletismography), and carbon dioxide percutaneous measurements monitored during the whole procedure (control and exploratory profile tests).
Time frame: pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6)
Visual Analog Scale (VAS) measurements of distress
Time frame: 3.5-4hours, 4.5-5.3hours, 5hours 20mins, 5hours 35mins, 5hours 43mins after public speaking, 6hours, 6hours 20mins, 7hours (week 1,2, and 3)
Maddox wing test.
Time frame: Week 1, 2 and 3
questionnaire for sédation.
Time frame: Week 1, 2 and 3
plasma levels of the various compounds to derive pharmacokinetic parameters
Time frame: 1hour, 2hours, 4-5hours, 8hours (week 1, 2 and 3)
Safety and tolerability will be evaluated by adverse event monitoring, physical examination, ECG, vital signs and laboratory parameters
Time frame: Up to 6 weeks

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 4 Aug 2017.
Results for study CRH108571 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

Related trials for Social Phobia

Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Social Anxiety Disorder, Social Fear
Active, not recruiting
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Autism Spectrum Disorder, Autism
Active, not recruiting
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Body Dysmorphic Disorder, Eating Disorders
RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
Social Anxiety Disorder (SAD)

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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK561679 tablet, GW876008 tablet and alprazolam in people with Social Phobia, run by GlaxoSmithKline at 8 sites in Spain.

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 10 inclusion and 26 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Changes of fMRI activation in amygdala of subjects with SAD during an emotional task after having received different compounds. Change in the VAS score in response to Public Speaking stress after having received different compounds. (time frame: over 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00555139.

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 4 Aug 2017.