A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb
About this trial
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
Participants must require hospitalization for the acute exacerbation or relapse of mania.
Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
Disqualifiers
Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
Trial design
Design model
Parallel
Treatments tested in this trial
KarXT
DrugSpecified dose on specified days
Placebo
Other interventionSpecified dose on specified days
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: KarXTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Young Mania Rating Scale (YMRS) score
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
Time frame
At week 3Secondary outcomes
1
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill).
Time frame
At week 32
Occurrence of response based on ≥ 50% decrease from baseline in YMRS score or total score
Time frame
At week 33
Occurrence of response based on change from baseline ≥ 1 in CGI-BP
Time frame
At week 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov