Generalized Anxiety Disorder
Conditions
Keywords
GAD
Brief summary
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
Interventions
Single, subcutaneous dose of RE104 for Injection
DRUGPlacebo
Single, subcutaneous dose of 0.9% sodium chloride for injection
Sponsors
Reunion Neuroscience Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Has Generalized Anxiety Disorder as defined by DSM-5-TR * If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant. * Is willing and able to comply with the conditions and requirements of the study
Exclusion criteria
* Has a significant risk of suicide * Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder * Has other concurrent psychiatric disorders that is the primary disorder. * Has other medically significant conditions rendering unsuitability for the study * Has used or will need to use prohibited medications or therapies * Has a known sensitivity or intolerance to study intervention or potential rescue medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) | Weeks 1, 2, 8 and 12 | 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. |
| RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline) | Weeks 1, 2, 4, 8 and 12 | 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. |
| RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7) | Day 1 and Weeks 1, 2, 4, 8 and 12 | 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. |
| RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore | Weeks 1, 2, 4, 8 and 12 | 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. |
| RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. | From dosing through study completion (post-dose follow-up is for 12 weeks) | 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. |
Countries
United States
Contacts
CONTACTMark Pollack Chief Medical Officer, M.D.
STUDY_DIRECTORMark Pollack, M.D.
Reunion Neuroscience Inc
Outcome results
None listed