Manic Episode Research Study
Researchers at Arch Clinical Trials are running a study to see how effective a new medication, KarXT, is for treating manic episodes in people with Bipolar I Disorder.
Fast Facts
Diagnosed With Bipolar-I Disorder & Have Had A Recent Manic Episode/Relapse Within The Last 3 Weeks
Willing To Be Inpatient As Part Of Study Participation
Compensation
Provided
Conducted in
Creve Coeur, MO
Study Background
This study is testing how effective KarXT is for treating manic episodes in people with Bipolar I Disorder.
This study is testing a new investigational medication called KarXT to see how effective it is in treating manic episodes in people with Bipolar I Disorder. It is a Phase 3, randomized, double-blind, placebo-controlled clinical trial, meaning that participants will be randomly assigned to receive either the study drug or a placebo, and neither the participants nor the study staff will know which treatment is being given. Before beginning the study, eligible participants will need to stop taking their current antipsychotic medications. All participants will stay at the inpatient facility for the duration of the study, which may last up to 36 days, including a follow-up outpatient visit after discharge.
During the inpatient stay, participants will complete 10 study visits involving physical exams, physician questionnaires, EKGs, and blood draws for lab work or study-related testing. The final follow-up visit will be done as an outpatient to monitor safety after treatment ends. The main goal of the study is to determine whether KarXT is an effective treatment option for managing manic episodes in individuals diagnosed with Bipolar I Disorder.
Study Background
This study is testing how effective KarXT is for treating manic episodes in people with Bipolar I Disorder.
This study is testing a new investigational medication called KarXT to see how effective it is in treating manic episodes in people with Bipolar I Disorder. It is a Phase 3, randomized, double-blind, placebo-controlled clinical trial, meaning that participants will be randomly assigned to receive either the study drug or a placebo, and neither the participants nor the study staff will know which treatment is being given. Before beginning the study, eligible participants will need to stop taking their current antipsychotic medications. All participants will stay at the inpatient facility for the duration of the study, which may last up to 36 days, including a follow-up outpatient visit after discharge.
During the inpatient stay, participants will complete 10 study visits involving physical exams, physician questionnaires, EKGs, and blood draws for lab work or study-related testing. The final follow-up visit will be done as an outpatient to monitor safety after treatment ends. The main goal of the study is to determine whether KarXT is an effective treatment option for managing manic episodes in individuals diagnosed with Bipolar I Disorder.
Additional Information
This study is being done to determine whether KarXT is an effective treatment for manic episodes in people with Bipolar I Disorder. Researchers hope it may offer a new option for managing symptoms during acute episodes.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with Bipolar-I disorder
- Experiencing an acute episode or relapse of mania within the past 3 weeks
- Willing to be inpatient as part of study participation
- Willing to discontinue all psychotropic medications
- At a healthy weight (BMI between 18-40 KG/m2)
- Ages 18-65
Exclusion Criteria
- Moderate to severe substance use disorder (except tobacco use disorder) within the last 12 months
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
- History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma
- Pregnant, lactating, or planning on become pregnant during the trial and follow up period
If you participate in this study, here’s what you can expect:
Screening – You’ll first go through a screening process to determine if you’re eligible for the study.
Medication Adjustment – If eligible, you’ll be required to stop taking your current antipsychotic medications before starting the study.
Inpatient Stay – You’ll stay at our inpatient facility for the main part of the study, which can last up to 36 days.
Randomization – You’ll be randomly assigned to receive either the study drug (KarXT) or a placebo. Neither you nor the study staff will know which one you receive.
Study Visits – While inpatient, you’ll complete 10 study visits that include medical checkups, questionnaires, vital signs, EKGs, and blood draws.
Follow-up Visit – After your inpatient stay, you’ll return once for a final outpatient safety follow-up visit.
Yes, you will be paid for participating in this research study. Participants receive $200 for each overnight stay at the inpatient facility (up to $5,000). If you live within 50 miles of the facility, transportation can be arranged through Lyft.
There is no cost for you to participate in our research study.