Health Condition 1: null- GENERALIZED ANXIETY DISORDER
Conditions
Interventions
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 p
Sponsors
LIBBS FARMACUTICA LTDA
Eligibility
Inclusion criteria
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 >= 18 on the Hamilton Anxiety Scale (HAM-A) at screening and randomization visit.
Exclusion criteria
Exclusion criteria: 1)Previous history of an inadequate response to buspirone and/or sertraline Inadequate response: no response to the treatment with the use of the full dose of buspirone (15 mg/day) or sertraline (50 mg/day) for at least 4 weeks of use. 2)Allergy or known hypersensitivity to buspirone or sertraline 3)Current diagnosis of Axis I disorders, other than GAD, and/or borderline, antisocial personality disorders as per DSM-IV-TR; 4)Diagnosis of convulsive disorders within the last 6 months (for example: epilepsy, epilepticus, cranial trauma) and/or current use of anticonvulsants 5)Serious organic cerebral syndromes 6)Patients with an uncontrolled and unstable clinical state considered clinically significant (e.g. renal, hepatic, endocrine, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease or malignant neoplasm) which may interfere in the interpretation of the safety and efficacy evaluations in accordance with the investigatorâ??s opinion 7)Patients with narrow-angle glaucoma 8)Regular use of the following medication: •Selective serotonin reuptake inhibitors in the last 28 days prior to date of randomization; •Anxiolytics, antipsychotics/neuroleptics, MAO inhibitors, mood stabilizers, anticonvulsants or other antidepressants in the last 14 days prior to date of randomization •Central nervous system stimulants and hypnotics (except for selective GABA(A) receptor alpha1 subunit agonists, such as zolpidem), betablockers, clonidine, sumatriptan, antihistamines that cause sedation, phytotherapeutics with an anxiolytic action in the last 7 days prior to date of randomization Regular Use: for this protocol is considered as the use of the medication described above for a period greater than or equal to 07 consecutive days Sporadic Use: is considered as the use of the medication described above for a period less than 07 consecutive days and patients with sporadic medication use can be included on trial if the medication use was stopped at least 7 days prior to randomization date. The frequency of use, dose and half-life of each drug must be considered in defining the sporadic use and justified on source documents by investigator; 9)Treatment for hyperthyroidism or hypothyroidism initiated, modified or interrupted within last 3 months 10)Psychotherapy treatment initiated or interrupted within last 3 months (Patients that have been in psychotherapy treatment for more than 3 months can be enrolled in the study provided they proceed with psychotherapy during the entire study and, if psychotherapy is required to be interrupted, the patient should be withdrawn from the study) 11)History of alcohol or illegal drug dependence within last 1 year 12)Participation in another clinical study or usage of any investigational product/ device within last 30 days 13)Patients who in the opinion of the principal investigator may not present adherence to the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total HAM-A scoreTimepoint: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactPrasann Bavania
Accutest Research Laboratories (I) Pvt. Ltd.
Outcome results
None listed