Tests treatment safety and results for Bipolar 1 Disorder
Official title Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
ClinicalTrials.gov ID: NCT07046494
What this study is testing
What is RAP-219?
RAP-219 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bipolar 1 disorder.
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 is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 65
You may be able to join if
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic...
- Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1
You likely can't join if
- History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or...
- Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Chino, California, United States
- Lemon Grove, California, United States
- Los Alamitos, California, United States
- Orange, California, United States
- San Diego, California, United States
- Boynton Beach, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Miami Lakes, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Gaithersburg, Maryland, United States
- St Louis, Missouri, United States
- Staten Island, New York, United States
- Charlotte, North Carolina, United States
- Austin, Texas, United States
- Houston, Texas, United States
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Chino, California, United States; Lemon Grove, California, United States; Los Alamitos, California, United States; Orange, California, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.