Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Etifoxine and Escitalopram: Etifoxine 50 mg TDS for 4 weeks as adjunct to Escitalopram 5 mg per day for 2 weeks and 10 mg per day for next 2 weeks
Control Intervention1: Clonazepam and
Sponsors
Dr Ethamakula Baby Padmasri
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 years or older up to 60 years old of either sex with capacity to consent Diagnosis of Generalized Anxiety Disorder as per DSM-5 criteria Baseline anxiety severity with HAM A score greater than or equal to 18 that is moderate or higher anxiety and baseline depression with HAM-D score less than or equal to 12 that is no or mild depression Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: History of other primary psychiatric disorders like current moderate and severe major depressive disorder bipolar disorder psychotic disorder or primary panic disorder History of substance abuse or dependence in the past 6 months Recent use of psychotropic medication or Patients who have taken another anxiolytic benzodiazepine buspirone etc or antidepressant for anxiety within the past 2 weeks History of adverse reactions to benzodiazepines or etifoxine Person with intellectual disability Pregnancy or lactation Patients with impaired liver function and renal function Patient of glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in GAD 7 and HAM A total score Timepoint: At baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response or remission greater than or equal to 50 percent reduction on HAM A or HAM A less than or equal to 7Timepoint: 4 weeks;Onset of anxiolytic effectTimepoint: 2 weeks;Side effect profile UKU ScaleTimepoint: 4 weeks;Overall functioning or clinical improvement CGI ITimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Ethamakula Baby Padmasri
All India Institute of Medical Sciences Vijaypur Jammu
Outcome results
None listed