General Anxiety Disorder
Conditions
Keywords
anxiety
Brief summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD
Interventions
DRUGENX-102
Four weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period
DRUGPlacebo
Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period
Sponsors
Engrail Therapeutics INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive * Diagnosed with GAD according to the DSM-V, confirmed by MINI * Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2 Key
Exclusion criteria
* Clinically predominant psychiatric diagnosis other than GAD per the MINI * Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder * Ingested prohibited medication within 5 half-lives prior to Day 1 * Current or recent moderate or severe substance use disorder as assessed by the MINI * Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial * Has significant progressive disorders or unstable medical conditions * Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 4 weeks | • Incidence and severity of treatment-emergent AEs (TEAEs) |
Countries
United Kingdom
Outcome results
None listed