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Recruiting NCT07002034

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

Phase II Interventional Adjustment 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.
Who it may be relevant to
Registry conditions: Adjustment Disorder. Basic parameters: 18 years — 80 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, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses

Overview

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.

Interventions

  • Drug RE104 for Injection
    Single, subcutaneous dose of RE104 for Injection

Primary outcome measures

  • RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score [Time frame: Day 7]
Secondary outcome measures (2)
  • RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) [Time frame: Day 7]
  • RE104 30 mg versus RE104 1.5 mg 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 42 days)]

Eligibility criteria

Inclusion criteria

  • 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
  • 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 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
  • 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 · 30 centers
  • UAB, Psychiatry and Behavioral Neurology — Birmingham
  • University of Arizona — Tucson
  • Kadima Neuropsychiatry Institute — San Diego
  • Providence Medical Foundation — Santa Rosa
  • University of Colorado — Aurora
  • University of South Florida, Department of Psychiatry and Behavioral Neuroscience — Tampa
  • Emory University — Atlanta
  • Hawaii Pacific Neuroscience — Honolulu
  • … and 22 more centers

Identifiers

NCT: NCT07002034 · RE104-202-ADCO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗