Phase III efficacy trial of Buspirone with comparison to Sertraline in treatment of General Anxiety Disorder

INTERVENTION: Intervention1: BUSPIRONE (ANSITEC) of Libbs Farmaceutica Ltda, Brazil: INITIAL DOSE (V1): 10mg/day (titration) â?? (5mg â?? 2 times per day) FULL TREATMENT DOSE (V2): 15mg/day â?? (5mg â?? 3 times per day) Further adjustment of the dose will be permitted on two occasions during the study, at V3 and V4, and these adjustments can be: 15mg to 20mg/day and subsequently from 20mg to 30mg/day, if applicable. Duration of Treatment: 14 weeks Control Intervention1: SERTRALINE (DAXID) of Pfizer Ltd., India: INITIAL DOSE (V1): 25mg/day (titration) â?? (once daily) FULL TREATMENT DOSE (V2): 50mg/day â?? (once daily) Further adjustment of the dose will be permitted on two occasions during the study, at V3 and V4, and these adjustments can be: 50mg to 100mg/day and subsequently from 100mg to 150mg/day, if applicable. Duration of Treatment: 14 weeks CONDITION: GENERALIZED ANXIETY DISORDER PRIMARY OUTCOME: Total HAM‐A score‐‐‐‐‐‐Timepoint: 9 weeks SECONDARY OUTCOME: 1. Total HAM‐A score ; 2. Treatment responders ; 3. Remissions ; 4.Total ZSRAS Score ; 5.CGI‐ I, ; 6.CGI‐S, E ; 7.Total PSWQ Score ; 8.The general impression of Investigator ; 9.The general impression of patient ; 10.discontinuations due to low efficacy ; ‐‐‐‐‐‐Timepoint: 1.at 1, 4, 6 and 9 weeks ; 2.at 1, 4, 6 and 9 weeks ; 3.at 4, 6 and 9 weeks ; 4.at 1, 4, 6 and 9 weeks ; 5.at 1, 4, 6 and 9 weeks ; 6.at 1, 4, 6 and 9 weeks ; 7.at 1, 4, 6 and 9 weeks ; 8. 9 weeks ; 9. 9 weeks ; 10. throughout study ; INCLUSION CRITERIA: 1)Men and women aged between 18 and 65 years with a diagnosis of GAD as per DSM‐IV‐TR. 2)Women without child bearing potential (for example, surgically sterilized or post‐menopausal for at least 1 year) or women that are not pregnant (confirmed by β‐HCG test at screening) or lactating and agreeing to use a contraceptive method accepted by the investigator during the study conduction. 3)Willing to give written informed consent before any procedure in the study has been conducted. (For application of the ICF refers to item 11.2) 4)Score â?¥ 18 on the Hamilton Anxiety Scale (HAM‐A) at screening and randomization visit.