A clinical trial to study the effects of two drugs, opipramol and alprazolam in the treatment of generalized anxiety disorder.
- Registration Number
- CTRI/2010/091/000296
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method