Subjects with Social Anxiety Disorder (SAD)
Conditions
Interventions
Product Code: GW597599
Pharmaceutical Form: Tablet
CAS Number: 334476-64-1
Current Sponsor code: GW597599B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharm
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has a primary diagnosis of Generalised 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. Note: a diagnosis of Generalised 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. 2. Male and female subjects must be 18-65 years of age. 3. Subjects must be willing to restrict alcohol intake to 3 units or less per day for males, 2 units or less per day for females. A unit is equivalent to 300 mL of beer or one measure of spirits or one glass of wine. 4. The subject must have the ability to comprehend the key components of the consent form and must have given written informed consent to participate in the study prior to commencing any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who score 1 or 2 on the CGI global improvement item at baseline. 2. Subjects with a score 15 or more on the HAMD17item at screening. 3. Subjects who meet DSM-IV criteria for any other Axis I disorder as a primary diagnosis at or within 6 months prior to the screening visit. 4. Subjects with body dysmorphic disorder. 5. Subjects with a history of schizophrenia, schizoaffective disorder, or a bipolar disorder. 6. Subjects who meet DSM-IV criteria for substance abuse (alcohol or drugs) currently or within 6 months prior to screening 7. Subjects who meet DSM-IV criteria for substance dependence (other than nicotine or caffeine) currently or within 6 months prior to screening. 8. Subjects have any screening laboratory value outside of the Sponsor-specified ranges at the Screening Visit. Testing may be repeated once to see if the value returns to within range but any such laboratory abnormality must be resolved by the Baseline Visit. 9. Subjects have any laboratory abnormality that in the Investigator’s judgement is considered to be clinically significant and not resolved by the Baseline Visit (even if not outside of Sponsor-specified ranges). 10. Subjects have a positive urine test at Screening for illicit drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months. Subjects have a blood alcohol level of =15 mg/dL (0.015%) at the Screening Visit. 11. Subjects with an unstable medical disorder; or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of GW597599 or paroxetine; may pose a safety concern; or interfere with the accurate assessment of safety or efficacy. 12. Subjects with a history of myocardial infarction within one year prior to the Screening Visit. 13. Subjects who are not euthyroid based on lab results at the Screening Visit. Subjects maintained in thyroid medication must be euthyroid for a period of at least six months prior to the Screening Visit. 14. Subjects have any screening electrocardiographic (ECG) parameter outside of the Sponsor-specified ranges; the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the Baseline Visit. 15. Subjects have any ECG finding that in the Investigator’s judgement is considered to be clinically significant and not resolved by the Baseline Visit. 16. Subjects who have taken any of the following psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) must have stopped taking these drugs within the time frames specified below prior to the Baseline Visit (for a listing see the protocol). All of the above psychotropic drugs are not allowed for the duration of the study, including the two-week period preceding the mandatory 14-Day Follow-up Visit. All other (non-psychotropic) drugs metabolised via the P450 3A4 pathway must be discontinued from screening and are not allowed for the duration of the study. 17. Subjects who are currently participating in another clinical trial in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to SAD, or 12 months for studies related to SAD. 18. Subjects who have received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the 6 months prior to the Screening Visit. 19. Subjects receiving or planning to undergo regular
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anxiolytic efficacy of GW597599/Paroxetine combination (15 mg and 7.5 mg, respectively/day) compared to placebo in outpatients with SAD.;Secondary Objective: To evaluate the anxiolytic efficacy of Paroxetine 7.5 mg/day monotherapy compared to placebo in outpatients with SAD. To evaluate the safety and tolerability of GW597599/Paroxetine combination (15 mg and 7.5 mg, respectively/day) and Paroxetine 7.5mg/day monotherapy compared to placebo in outpatients with SAD. Pharmacokinetic/pharmacodynamic (PK/PD) link between individual GW597599 and Paroxetine plasma concentration time course and individual changes on the LSAS and CGI scores. To assess the agreement between the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score and the IVRS LSAS total score.;Primary end point(s): Change from baseline in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score at Week 12 LOCF. The primary comparison of interest is GW597599/Paroxetine combination versus placebo. | — |
Countries
Denmark, Germany
Outcome results
None listed