Adjustment Disorder study: RE104 for Injection
Official title RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
ClinicalTrials.gov ID: NCT07002034
What this study is testing
What is RE104 for Injection?
This is an investigational injectable medicine being studied to see if it helps reduce depressive or anxiety symptoms in people with Adjustment Disorder caused by serious illnesses.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a single dose of RE104 injection can reduce depression or depression with anxiety in people with adjustment disorder caused by cancer or other illnesses.
- Who it's for
- You may be able to join if you have adjustment disorder from cancer, ALS, MS, Parkinson's, or IPF.
- What's involved
- You will receive one injection of RE104 or a pretend treatment. You will have visits to check symptoms and side effects.
- Time commitment
- The study lasts a few weeks, with a few visits after the injection.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- Has a significant risk of suicide
- Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality...
- Has a history of current active 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
See the full eligibility 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...
- 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
- 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 a history of current active 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Shreveport, Louisiana, United States
- Rockville, Maryland, United States
- Towson, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Novi, Michigan, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
- New York, New York, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Tucson, Arizona, United States; San Diego, California, United States; Aurora, Colorado, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.