The purpose of this study is to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Single dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection
Single-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection
RE104 when administered as a single 30 mg dose or as two 30 mg doses 3 weeks apart versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Time frame: Week 4
RE104 versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Time frame: Weeks 1, 2, 8 and 12
RE104 versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Time frame: Weeks 1, 2, 4, 8 and 12
RE104 versus placebo percentage of participants with HAM-A remission (total score ≤7)
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Time frame: Day 1 and Weeks 1, 2, 4, 8 and 12
RE104 versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore
The Hospital Anxiety and Depression Scale (HADS) is a self-reported scale measure the severity of depression and anxiety in patients with comorbid medical conditions. The scale consists of 14 items (7 for anxiety and 7 for depression), with a score ranging between 0 and 21 for the anxiety and depression subscales.
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University of Alabama (UAB) Clinical Research Unit (CRU)
Birmingham, Alabama, United States
RECRUITINGLighthouse Psychiatry
Gilbert, Arizona, United States
RECRUITINGPreferred Research Partners, Inc.
Little Rock, Arkansas, United States
RECRUITINGCollaborative Neuroscience Research, LLC
Garden Grove, California, United States
RECRUITINGKadima Neuropsychiatry Institute
La Jolla, California, United States
RECRUITINGOpen Mind Therapeutics
San Francisco, California, United States
RECRUITINGTRIP Clinic at Psychedelic Science Institute
Santa Monica, California, United States
RECRUITINGInnovative Clinical Research, Inc.
Lauderhill, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGAtlanta Center for Medical Research
Atlanta, Georgia, United States
RECRUITING...and 18 more locations
Time frame: Weeks 1, 2, 4, 8 and 12
RE104 versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Time frame: From dosing through study completion (post-dose follow-up is for 12 weeks)
RE104 versus placebo change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) (Part B only)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.
Time frame: Weeks 1, 2, 4, 8, and 12