RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
ConditionGeneralized Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorReunion Neuroscience Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RE104 for Injection
DrugSingle dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection
Placebo
DrugSingle-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 30 mg RE104Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 4Secondary outcomes
1
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 122
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 123
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 124
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.
Time frame
Weeks 1, 2, 4, 8 and 12Sponsors and contacts
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Source ClinicalTrials.gov