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Taking people in RomaniaPhase 3

Long-term safety of KarXT in adults with bipolar I mania

Studies the long-term safety of KarXT in adults with bipolar I mania.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Bucharest, Jassi, and loc Sanpetru, jud Brasov, RomaniaSee the 6 sitesAlso in 19 other countries, 167 sites
Trial code
Registry title
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
18 Jul 2025
Expected to end
13 Jun 2028
Type of study
Interventional
Treatments tested
  • KarXT
  • Lithium
  • Valproate
  • Lamotrigine
Record updated
26 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with mania or mania with mixed features in Bipolar-I disorder, to check the long-term safety of KarXT. It is open to people who finished one of the earlier studies and to new participants.

Age
18 to 65 years.
Sex
All sexes can join.
Disease stage
Bipolar-I disorder with mania or mixed mania. New participants must not need hospital care for acute mania. They need a Young Mania Rating Scale score of 14 or more and a CGI-BP score of 3 or more at screening and at baseline.
Earlier treatment
People from the earlier double-blind studies (CN0120036, CN0120037 or CN0120046) must have completed the treatment period of that study. New participants did not take part in those studies.

Main reasons for not taking part

  • Risk of suicidal behavior now, or a history of suicidal behavior
  • Stopped KarXT early in an earlier study
  • Bipolar-I with rapid cycling (4 or more mood episodes in one year)
  • Moderate to severe substance use disorder in the past 12 months, or current use
  • History of irritable bowel syndrome, serious constipation, urinary retention, gastric retention or untreated narrow-angle glaucoma

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):; Participants must have completed treatment period of parent study
  • De novo participants who did not participate in double-blind placebo-controlled studies:; Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania; Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline; Participants must have CGI-BP score of ≥ 3 at Screening and at baseline; Participants does not require hospitalization for acute mania

Who cannot take part

  • De novo participants who did not participate in double-blind placebo-controlled studies:; Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year); Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders; Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test; Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months; Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma
  • All participants:; All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS
  • Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):; Discontinuation from any KarXT parent studies
  • Other protocol-defined Inclusion/Exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Romania

Also in 19 other countries, 167 sites

  • Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. StelianBucharest, RomaniaTaking people
  • Institutul Național de Gerontologie și Geriatrie "Ana Aslan"Bucharest, RomaniaTaking people
  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
  • Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'Bucharest, RomaniaTaking people
  • Institutul De Psihiatrie Socola IasiJassi, RomaniaTaking people
  • Spitalul Clinic De Psihiatrie Si Neurologie Brasovloc Sanpetru, jud Brasov, RomaniaTaking people

About the trial

What the trial wants to find out

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)

Read full original descriptionShow less

The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

The group in the trial

  • KarXT or Adjuvant KarXTTreatment being tested

    Treatment: KarXT, Lithium, Valproate, and Lamotrigine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
Plain-language title
Long-term safety of KarXT in adults with bipolar I maniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06929273, who can take part
Record updated
26 October 2026