A Study to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP Plus Clonazepam IP Tablets in patients with anxiety disorders.

Phase 4

• Conditions: Health Condition 1: F411- Generalized anxiety disorder

• Registration Number: CTRI/2020/07/026634
• Lead Sponsor: Akums Drugs Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants who experienced at least one adverse event (AE) <br/ ><br>�Proportion of discontinuations due to AEs <br/ ><br>�Incidence of Serious AEs <br/ ><br>�Changes in the laboratory parameters from baseline to the end of treatment. <br/ ><br>Timepoint: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Severity Scale (CGI-S) <br/ ><br> <br/ ><br>Clinical Global Impression-Anxiety Scale (CGI-anxiety) <br/ ><br> <br/ ><br>Clinical Global Impression-Sleep Scale (CGI-sleep).Timepoint: Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6