Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Fixed Dose Combination (FDC) Propranolol Hydrochloride IP 10MG / 10MG / 20MG /20MG and Clonazepam IP 0.25MG / 0.5MG / 0.25MG /0.5MG: 1 tablet of suitable strength of FDC of Propranolol
Sponsors
Akums Drugs Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients age 18 - 65 years. 2. Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohavenapproved board-eligible psychiatrist; The duration of illness must be >= 1 year 3. Hamilton Anxiety Scale (HAM-A) score at least 14. 4. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed. 5. Literate and can understand and sign informed consent. 6. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female patients. 2. Hypersensitivity and/or skin reactions to drug constituents 3. Patients with congestive heart failure 4. Patients with bronchospastic lung disease, or severe respiratory insufficiency 5. Patients planned to be undergoing any major surgery 6. Patients with diabetes and specifically prone to hypoglycaemia 7. Patients with a history of hypothyroidism 8. Wolf-Parkinson-White Syndrome and tachycardia 9. Patients with impaired hepatic or renal function 10. Patients with sleep apnoea, myasthenia gravis and narrow-angle glaucoma. 11. Patients using any of the prohibited medications: a) Opioids) Use of alcohol/CNS depressants c) Antiepileptic drugs phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate d) drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways e) Cardiovascular drugs: antiarrhythmics, Digitalis Glycosides, Calcium Channel Blockers, ACE Inhibitors, Alpha Blockers, Reserpine, inotropic agents, Isoproterenol and Dobutamine, f) Nonsteroidal Anti-Inflammatory Drugs, Antidepressants, Anesthetic Agents, Warfarin, Neuroleptic Drugs, Thyroxine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who experienced at least one adverse event (AE) â?¢Proportion of discontinuations due to AEs â?¢Incidence of Serious AEs â?¢Changes in the laboratory parameters from baseline to the end of treatment. Timepoint: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Severity Scale (CGI-S) Clinical Global Impression-Anxiety Scale (CGI-anxiety) Clinical Global Impression-Sleep Scale (CGI-sleep).Timepoint: Day 1/Week 1; Day 15±2/ Week 3 ; Day 42±2/ Week 6 | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed