Recruiting NCT07489651
RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RE104 for Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Generalized Anxiety Disorder. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder
Overview
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
- Drug RE104 for Injection
Single, subcutaneous dose of RE104 for Injection - Drug Placebo
Single, subcutaneous dose of 0.9% sodium chloride for injection
Primary outcome measures
- RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score [Time frame: Week 4]
Secondary outcome measures (5)
- RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) [Time frame: Weeks 1, 2, 8 and 12]
- RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline) [Time frame: Weeks 1, 2, 4, 8 and 12]
- RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7) [Time frame: Day 1 and Weeks 1, 2, 4, 8 and 12]
- 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 [Time frame: Weeks 1, 2, 4, 8 and 12]
- RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. [Time frame: From dosing through study completion (post-dose follow-up is for 12 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 22 centers
- Lighthouse Psychiatry — Gilbert
- Preferred Research Partners, Inc. — Little Rock
- Collaborative Neuroscience Research, LLC — Garden Grove
- Kadima Neuropsychiatry Institute — La Jolla
- Open Mind Therapeutics — San Francisco
- TRIP Clinic at Psychedelic Science Institute — Santa Monica
- Innovative Clinical Research, Inc. — Lauderhill
- University of South Florida — Tampa
- … and 14 more centers
Identifiers
NCT: NCT07489651 · RE104-203-GAD