Adjustment DisorderPhase 2NCT07002034
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
A Phase 2 study testing RE104 for Injection in people with Adjustment Disorder, run by Reunion Neuroscience Inc at 32 sites in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adjustment Disorder
- What is being tested?
- RE104 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 32 sitesUnited States
- Study dates
- 30 Jul 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
United States32 sites, 32 recruiting
- Recruiting
University of New Mexico, School of Medicine
Albuquerque, New Mexico, 87131
Hector Garcia, hecgarcia@salud.unm.edu
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
OCTSU Team, RE104_researchermm@med.umich.edu
- Recruiting
Emory University
Atlanta, Georgia, 30329
Joyelle Van Eron, 404-727-8966, joyelle.van.eron@emory.edu
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Mary Mancuso, MARY.MANCUSO@CUANSCHUTZ.EDU
- Recruiting
Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
Kelly Jackson, 561-777-5684, kelly.jackson@austin.utexas.edu
- Recruiting
UAB, Psychiatry and Behavioral Neurology
Birmingham, Alabama, 35209
Seher Premani, 205-996-1198, spremani@uab.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Gabriel Najarian, gabriel_najarian@dfci.harvard.edu
- Recruiting
Roswell Park Center Institute
Buffalo, New York, 14263
William Alexander, 716-845-1300 ext. 3657, William.Alexander@RoswellPark.org
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Rachel Grace Kozik, rachel_kozik@med.unc.edu
- Recruiting
UVA Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903
Ashley Kahler, ALG7GH@uvahealth.org
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Linda Skaggs, Linda_Skaggs@rush.edu
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Ana Delariva, 773-795-2378, Ana.Delariva@bsd.uchicago.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44113
Katelyn Schwesinger, 216-425-7426, psychresearch@ccf.org
- Recruiting
The Ohio State University, Department of Psychiatry
Columbus, Ohio, 43210
Anne-Marie Duchemin, anne-marie.duchemin@osumc.edu
- Recruiting
Cedar Clinical Research Inc.
Draper, Utah, 84020
Kye Cutrubus, kye.cutrubus@numinusnetwork.com
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Peter Nguyen, pnguyen@hawaiineuroscience.com
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Travis Martin, tmartin5@kumc.edu
- Recruiting
Alliance for Multispecialty Research Clinical
Knoxville, Tennessee, 37920
Amy Rushing, 865-659-0406, amy.rushing@amr-clinical.com
- Recruiting
University of Wisconsin at Madison
Madison, Wisconsin, 53792
Zachary Stowe, zstowe@wisc.edu
- Recruiting
NYU Langone Health
New York, New York, 10016
Kahini Patel, kahini.patel@nyulangone.org
- Recruiting
Henry Ford Health
Novi, Michigan, 48377
Madeline Bross, 248-344-7366, mbross1@hfhs.org
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Kelsey Noble, kenoble@unmc.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Blase, 215-746-6419, erin.blase@pennmedicine.upenn.edu
- Recruiting
Sunstone Therapies, PC
Rockville, Maryland, 20850
Reunion Investigational Site, info@reunionneuro.com
- Recruiting
Kadima Neuropsychiatry Institute
San Diego, California, 92037
Isabella Newell, 858-775-2053, isabellan@kadimanp.com
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
Melissa Ulrich, Melissa.Ulrich@providence.org
- Recruiting
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
Libby Kell, Reunion.Rekindle@seattlentc.com
- Recruiting
LSU Health Shreveport
Shreveport, Louisiana, 71103
James Ryan Parker, james.parker@lsuhs.edu
- Recruiting
University of South Florida, Department of Psychiatry and Behavioral Neuroscience
Tampa, Florida, 33613
Yvonne Bannon, 813-974-2832, ybannon@usf.edu
- Recruiting
Sheppard Pratt
Towson, Maryland, 21204
Jeff LaPratt, Jeffrey.LaPratt@sheppardpratt.org
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Esmeralda Terrazas, (520) 626-4804, esmeralda97h@arizona.edu
- Recruiting
University of Massachusetts Chan Medical Center
Worcester, Massachusetts, 01655
Michelangela Yusif, 774-455-4136, Michelangela.Yusif@umassmed.edu
About this study
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
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.
- Conditions
- Adjustment Disorder
- Being tested
- RE104 for Injection
- Keywords
- Cancer, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), Idiopathic Pulmonary Fibrosis (IPF), Depression, Anxiety, Psychiatric Distress
- Medical subject headings
- Adjustment Disorders, Neoplasms, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Idiopathic Pulmonary Fibrosis, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE104 for InjectionDrug
Single, subcutaneous dose of RE104 for Injection
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg RE104 | Active comparator | A single subcutaneous injection of 1.5 mg RE104 for Injection Receives: Drug: RE104 for Injection |
| 30 mg RE104 | Experimental | A single subcutaneous injection of 30 mg RE104 for Injection Receives: Drug: RE104 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7
Secondary outcomes (2)
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.
Measured: Day 7
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.
Measured: From dosing through study completion (post-dose follow-up is for 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start30 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reunion Neuroscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pollack, Chief Medical Officer, Study director, Reunion Neuroscience Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002034
- Sponsor's protocol ID
- RE104-202-ADCO
- Status last verified
- Aug 2026
- First submitted
- 23 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07002034
- Acronym / sponsor ID
- RE104-202-ADCO
- Conditions
- Adjustment Disorder
- Keywords
- Cancer, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), Idiopathic Pulmonary Fibrosis (IPF), Depression, Anxiety, Psychiatric Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Reunion Neuroscience IncIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg RE104 | Active comparator | Drug: RE104 for InjectionA single subcutaneous injection of 1.5 mg RE104 for Injection |
| 30 mg RE104 | Experimental | Drug: RE104 for InjectionA single subcutaneous injection of 30 mg RE104 for Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE104 for InjectionSingle, subcutaneous dose of RE104 for Injection | Drug | 1.5 mg RE104, 30 mg RE104 |
Primary outcome
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Time frame: Day 7
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Pollack, Chief Medical Officer study director
Reunion Neuroscience Inc
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RE104 for Injection in people with Adjustment Disorder, run by Reunion Neuroscience Inc at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Pollack, Chief Medical Officer (1-888-880-REUN, info@reunionneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.