A clinical trial to study the effects of two drugs, opipramol and alprazolam in the treatment of generalized anxiety disorder

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: Opipramol (G3040):: 200 mg in divided doses Control Intervention1: Alprazolam (U31889): 0.5 mg to 3 mg three times daily CONDITION: In the treatment of generalized anxiety disorder. PRIMARY OUTCOME: Average change from baseline to end of trial in HAM‐A total score.‐‐‐‐‐‐Timepoint: Day 0, Day 14, Day 28 SECONDARY OUTCOME: 1. Average change from baseline to end of trial in Clinical Global Impression on Severity (CGI‐S). ; 2. Clinical Global Impression on Improvement (CGI‐I) in patients.; ‐‐‐‐‐‐Timepoint: 1. Day 0, Day 28,; 2. Day 14, Day 28.; INCLUSION CRITERIA: 1. Male or female patients aged between 18 and 65 years. 2. Patient has a primary diagnosis of generalized anxiety disorder according to Diagnostic and Statistical Manual of Mental disorder IV Text Revision (DSM‐IV TR) (See Appendix‐I). 3. Patients having total score of minimum of 17 on Hamilton Rating Scale of Anxiety. 4. Patient willing to give their informed consent.
Epistemonikos ID: 45da9a6c4ff9f7322e9b350894734d16810425c1
First added on: Aug 22, 2024