Study CRH103390: A 12 Week Flexible Dose Study of GW876008, Placebo and Active Control (Paroxetine) in the Treatment of Social Anxiety Disorder (SocAD)

• Conditions: Social Anxiety Disorder (SocAD); MedDRA version: 8.1Level: LLTClassification code 10041242Term: Social anxiety disorder

• Registration Number: EUCTR2006-003597-10-FI
• Lead Sponsor: GlaxoSmithKline Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria
apply:
1. Male or female subject must be 18-64 years of age inclusive.
2. Subject must have the ability to comprehend the key components of the consent
form, and provide written informed consent.
3. The subject must have a primary diagnosis of Generalized Social Anxiety
Disorder/Social Phobia as defined in the Diagnostic and Statistical Manual of Mental
Disorders, 4th Edition, (DSM-IV, 300.23) diagnosed using psychiatric confirmation
of diagnosis in conjunction with the Mini International Neuropsychiatric Interview
(MINI), Clinician Rated Version 5.0.0., 2006.
NOTE: A diagnosis of Generalized Social Anxiety Disorder will be considered to
have been established if the subject reports/admits to four or more phobic situations
including at least two which are interactional situations.
4. Subject is required to have a LSAS score = 60 at Screening and Randomization Visits
5. If female, the subject is eligible to enter and participate in this study if she is not
lactating and is of:
a. non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is pre-menarchal or post-menopausal
[defined as one year without menses]); is surgically sterile [via hysterectomy
and/or removal of the ovaries] or,
b. child-bearing potential, has a negative pregnancy test at both Screen and
Randomization Visits (prior to Investigational Product administration), and
agrees to one of the following methods of contraception:
• complete abstinence from intercourse two weeks prior to administration of
study drug, throughout the clinical trial, until the completion of follow-up
procedures) or for two weeks following discontinuation of the
Investigational Product in cases where subject discontinues the study
prematurely. (Subjects utilizing this method must agree to use an alternate
method of contraception if they should become sexually active and will be
queried on whether they have been abstinent in the preceding 2 weeks when
they present to the clinic for the Follow-Up Visit.) or,
• has a male sexual partner who is surgically sterilized (vasectomy with
documentation of azoospermia) prior to the Screening Visit or,
• sexual partner(s) is/are exclusively female or,
• Oral contraceptives (either combined or progestogen only), injectable
progestogen, implants of levonorgestrel, estrogenic vaginal ring and
percutaneous contraceptive patches must be used with double-barrier
method of contraception (see below). Women of child-bearing potential
using an oral contraceptive in combination with a double-barrier method of
contraception are required to continue to use this form of contraception for
1 week following discontinuation of Investigational Product.
• Double barrier method: condom or occlusive cap (diaphragm or
cervical/vault caps) plus spermicidal agent
(foam/gel/film/cream/suppository). The subject must be using this method
for at least 1 week following the discontinuation of Investigational Product
or,
• Any intrauterine device (IUD) with published data showing that the highest
expected failure rate is less than 1% per year. Acceptable IUDs, for the
purposes of this study, include TCu-380A (Paragard), TCU-380 Slimline
(Gyne T Slimline), MULTILOAD-250 (MLCu-250) and 375,
Levonorgesterol LNG-20 Intrauterine System (Mirena/Levonova), and
Flexigard 330/CuFix PP330 (Gynefix).The subject must have had the
device inserted at least 2 weeks pri

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Subject who scores 1 or 2 on the CGI-I score item at the Randomization Visit.
2. Subject who meets DSM-IV criteria for Major Depressive Disorder or who scores
=15 on the HAMD-17 at Screening Visit.
3. Subject’s LSAS assessment increases or decreases by more than 25% between the Screening and Randomization Visits.
4. Subject:
• Has symptoms of the presenting illness which are better accounted for by another diagnosis; or
• Meets DSM-IV criteria for any other Axis I disorder such as stated in protocol, as a primary diagnosis currently or within 6 months prior to the Screening Visit.
• Has current DSM-IV-TR diagnosis of Antisocial or Borderline Personality
Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or
• Has a current diagnosis of anorexia nervosa or bulimia; or a history of Schizophrenia, Schizoaffective or Bipolar Disorder.
5. Subject who poses a current, serious suicidal or homicidal risk, or has attempted suicide within the past 6 months or has ever been homicidal.
6. Subject has had electroconvulsive therapy or transcranial magnetic
stimulation within the 6 months prior to the Screening Visit.
7. Subject who is currently receiving regularly scheduled psychotherapy or plans to initiate psychotherapy during the trial or has received regularly scheduled psychotherapy during the 12 week period prior to the Screening Visit.
8. Subject has a positive urine test at screening for illegal drug use and/or history of
substance abuse or dependence within the past 12 months. Subject has a blood alcohol level of = 15mg/dL at the Screening Visit.
9. Subject has an unstable medical disorder; or a disorder that would likely interfere
with GW876008, or paroxetine
10. Subject has any laboratory abnormality that in the investigator’s judgment is
considered to be clinically significant and not resolved by the Randomization Visit.
11. Subject has a systolic blood pressure > 160 mmHg or a diastolic blood
pressure = 100 mmHg at the Screening or Randomization Visit.
12. Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis at Screening.
13. Subject who is not euthyroid as evidenced by normal Thyroid stimulating hormone.
14. Female subject who has a positive serum HCG pregnancy test at the Screen Visit, a positive urine dipstick test at the Randomization Visit , or who is lactating or planning to become pregnant within the next 18 weeks following the Screen Visit.
15. Subject has any electrocardiographic parameter outside of the Sponsor specified ranges at either screen or randomization visit.
16. Subject has taken other psychoactive drugs within two weeks prior to the
Randomization Visit including
• All antidepressants as described in protocol. All psychotropic drugs described in the protocol, are not allowed for the duration of the study, including the 2-week period preceding the mandatory 14-day Follow-up Visit.
17. Subject has taken systemic corticosteroids within two weeks of the Randomization Visit.
18. Subject who is likely to require the use of the following medications:
• Chronic (for more than 2 weeks), regular NSAID use unless administered concomitantly with an anti-secretory agent, i.e. proton-pump inhibitor or histamine-2 receptor antagonist.
• Concomita

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the anxiolytic efficacy of two dose ranges of GW876008 compared to<br>placebo in outpatients with SocAD.;Secondary Objective: To evaluate the efficacy of two dose ranges of GW876008 compared to placebo in<br>outpatients with SocAD on the following:<br>• Anxiety symptoms<br>• Disability<br>• Sleep;Primary end point(s): Key Decision Making Endpoints<br>• Change from randomization in the clinician-administered LSAS total score at the end<br>of the treatment phase (Week 12).<br>• Change from randomization on the LSAS Fear subscale score at Week 12.<br>• Change from randomization on the LSAS Avoidance subscale score at Week 12.<br>• Change from randomization on the Social Avoidance and Distress Scale (SADS)<br>total score at Week 12.