Social Anxiety Disorder (SocAD) MedDRA version: 8.1 Level: LLT Classification code 10041242 Term: Social anxiety disorder
Conditions
Interventions
Product Name: GW876008
Product Code: GW876008
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 ever had vagus nerve stimulation, or has received electroconvulsive therapy (ECT) 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 the action, absorption, distribution, metabolism, or excretion of GW876008, or paroxetine, may pose a safety concern (including Type I diabetic patients and type II diabetic patients requiring pharmacological treatment); or interfere with the accurate assessment of safety or efficacy. 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 corticosteroi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the efficacy of two dose ranges of GW876008 compared to placebo in outpatients with SocAD on the following: • Anxiety symptoms • Disability • Sleep;Main Objective: To evaluate the anxiolytic efficacy of two dose ranges of GW876008 compared to placebo in outpatients with SocAD.;Primary end point(s): Key Decision Making Endpoints • Change from randomization in the clinician-administered LSAS total score at the end of the treatment phase (Week 12). • Change from randomization on the LSAS Fear subscale score at Week 12. • Change from randomization on the LSAS Avoidance subscale score at Week 12. • Change from randomization on the Social Avoidance and Distress Scale (SADS) total score at Week 12. | — |
Countries
Finland, Germany, Sweden
Outcome results
None listed