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RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

ConditionAdjustment Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorReunion Neuroscience Inc

About this trial

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF

Is sufficiently ambulatory and capable of self care as necessary to complete study procedures

Has normal cognitive function

Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study

Disqualifiers

Has a significant risk of suicide

Has 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 active or a history of central nervous system malignancy

Has other medically significant conditions rendering unsuitability for the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • RE104 for Injection

    Drug

    Single, subcutaneous dose of RE104 for Injection

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 1.5 mg RE104Active comparator 1 intervention
Group B: 30 mg RE104Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score

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
Day 7

Secondary outcomes

1

RE104 30 mg versus RE104 1.5 mg 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
Day 7
2

RE104 30 mg versus RE104 1.5 mg 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 42 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Reunion Neuroscience Inc

Lead sponsor

Source ClinicalTrials.gov
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