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

Evaluation of efficacy and safety of opipramol versus alprazolam in the treatment of generalized anxiety disorder: a randomized, open label, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000296

Enrollment

200

Registered

2010-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Opipramol (G3040):: 200 mg in divided doses Control Intervention1: Alprazolam (U31889): 0.5 mg to 3 mg three times daily

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patients with known hypersensitivity to Opipramol (G3040) or Alprazolam (U31889) or any of the excipients of this formulation. 3. Patients taking MAO inhibitors. 4. Patients with acute narrow angle glaucoma. 5. Patients with prostate hypertrophy. 6. Alcohol abused patients. 7. Patients having severe renal and hepatic impairment. 8. Patients who displayed marked suicidal intent or known suicidal tendencies.

Design outcomes

Primary

Measure	Time frame
Average change from baseline to end of trial in HAM-A total score.Timepoint: Day 0, Day 14, Day 28	—

Secondary

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results