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

Conditions

• Adjustment Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• RE104 for Injection — DRUG
  Single, subcutaneous dose of RE104 for Injection

Study Details

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.

Key Dates

Start date

Jul 30, 2025

Status verified

May 2026

Primary completion

Nov 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1.5 mg RE104
  A single subcutaneous injection of 1.5 mg RE104 for Injection
• Experimental: 30 mg RE104
  A single subcutaneous injection of 30 mg RE104 for Injection

Primary Outcome Measure

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score [ Time Frame: Day 7 ]

Central Contacts

• Mark Pollack, Chief Medical Officer
  1-888-880-REUN
  [email protected]

Locations (30)

Find similar trials in Birmingham, AL

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