A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With... | NCT07140913 | Trialant

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With... | NCT07140913 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.

Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).

The individual requires hospitalization for the acute exacerbation or relapse of mania.

Body mass index ≥ 18 and ≤ 40 kg/m2.

Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.

YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline.

Exclusion Criteria:

Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive 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.

Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.

History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.

History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.

Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.

Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome.

All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).

Other protocol-defined Inclusion/Exclusion criteria apply.

Pillar Clinical Research - BentonvilleRecruiting

Bentonville, Arkansas 72712, United States

Fayz Hudefi, Site 0029Contact

479-367-2688

Pillar Clinical Research- Little RockRecruiting

Little Rock, Arkansas 72204, United States

Clinical Innovations, Inc. dba CITrialsRecruiting

Bellflower, California 90706, United States

Inland Psychiatric Medical Group.Recruiting

Chino, California 91710, United States

Proscience Research GroupRecruiting

Culver City, California 90230, United States

Omega Clinical Trials - La HabraRecruiting

La Habra, California 90631, United States

Catalina Research Institute, LLCRecruiting

Montclair, California 91763, United States

NRC Research InstituteRecruiting

Orange, California 92868, United States

Clinical Innovations, Inc. dba CITrialsRecruiting

Riverside, California 92506, United States

Velocity Clinical Research, Hallandale BeachRecruiting

Hallandale, Florida 33009, United States

South Florida Research Phase I-IVRecruiting

Miami, Florida 33166, United States

Health Synergy Clinical ResearchRecruiting

West Palm Beach, Florida 33407, United States

CenExel iResearch, LLCRecruiting

Savannah, Georgia 31405, United States

Pillar Clinical Research -ChicagoRecruiting

Chicago, Illinois 60641, United States

Arch Clinical TrialsRecruiting

St Louis, Missouri 63141, United States

Richmond Behavioral AssociatesRecruiting

Staten Island, New York 10314, United States

Community Clinical ResearchRecruiting

Austin, Texas 78754, United States

Elevate Clinical Research-HoustonRecruiting

Houston, Texas 77058, United States

Prime Clinical Research - MansfieldRecruiting

Mansfield, Texas 76063, United States

Pillar Clinical Research - RichardsonRecruiting

Richardson, Texas 75080, United States

Local Institution - 0011Not yet recruiting

ABB, Buenos Aires F.D. C1199ABB, Argentina

Site 0011Contact

Local Institution - 0010Not yet recruiting

Córdoba, 5000, Argentina

Local Institution - 0012Not yet recruiting

Córdoba, 5000, Argentina

Local Institution - 0008Not yet recruiting

Córdoba, X5003DCE, Argentina

Local Institution - 0009Not yet recruiting

Mendoza, 5502, Argentina

Local Institution - 0114Not yet recruiting

Santiago del Estero, 4200, Argentina

Local Institution - 0184Not yet recruiting

Kazanlak, Stara Zagora 6100, Bulgaria

State Psychiatric Hospital Sv. Ivan Rilski Novi IskarRecruiting

Novi Iskar, 1282, Bulgaria

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EADRecruiting

Pleven, 5800, Bulgaria

Local Institution - 0181Not yet recruiting

Sliven, 8800, Bulgaria

Local Institution - 0086Not yet recruiting

Targovishte, 7700, Bulgaria

Local Institution - 0185Not yet recruiting

Beijing, Beijing Municipality 100088, China

Local Institution - 0190Not yet recruiting

Beijing, Beijing Municipality 100096, China

Local Institution - 0191Not yet recruiting

Guangzhou, Guangdong 510370, China

Local Institution - 0193Not yet recruiting

Baoding, Hebei 071000, China

Local Institution - 0187Not yet recruiting

Shijiazhuang, Hebei 050031, China

Local Institution - 0196Not yet recruiting

Nanjing, Jiangsu 210029, China

Local Institution - 0186Not yet recruiting

Xi'an, Shaanxi 710061, China

Local Institution - 0192Not yet recruiting

Chengdu, Sichuan 610036, China

Local Institution - 0188Not yet recruiting

Tianjin, Tianjin Municipality 300022, China

Local Institution - 0197Not yet recruiting

Ningbo, Zhejiang 315201, China

Local Institution - 0195Not yet recruiting

Changsha, 450052, China

Local Institution - 0088Not yet recruiting

Hillerød, Capital Region 3400, Denmark

Local Institution - 0054Not yet recruiting

Aalborg, North Denmark 9000, Denmark

Local Institution - 0091Not yet recruiting

Glostrup Municipality, 2600, Denmark

Local Institution - 0126Not yet recruiting

Nice, Alpes-Maritimes 06000, France

Local Institution - 0085Not yet recruiting

Clermont-Ferrand, Puy-de-Dôme 63000, France

Local Institution - 0087Withdrawn

Marseille, 13274, France

Local Institution - 0129Not yet recruiting

Montpellier, 34295, France

Local Institution - 0089Withdrawn

Paris, 75014, France

Local Institution - 0121Not yet recruiting

Mangalore, Karnataka 575003, India

Local Institution - 0123Not yet recruiting

Madurai, Tamil Nadu 625020, India

Local Institution - 0118Not yet recruiting

Kolkata, West Bengal 700025, India

Local Institution - 0116Not yet recruiting

Kolkata, 700014, India

Local Institution - 0052Not yet recruiting

Hod HaSharon, Central District 4534708, Israel

Sheba Medical CenterRecruiting

Ramat Gan, Central District 5265601, Israel

Linda Levi-Haramati, Site 0050Contact

0585950299

Local Institution - 0053Not yet recruiting

Ashkelon, Southern District 7830604, Israel

Be'er Sheva Mental Health CenterRecruiting

Beersheba, Southern District 8461144, Israel

Local Institution - 0083Not yet recruiting

Jerusalem, 9112001, Israel

Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting

Milan, Lombardy 20122, Italy

Local Institution - 0005Not yet recruiting

Pisa, Tuscany 56126, Italy

Azienda Ospedaliero Universitaria SeneseRecruiting

Siena, Tuscany 53100, Italy

Local Institution - 0004Not yet recruiting

Ancona, 60126, Italy

Local Institution - 0002Not yet recruiting

Genova, 16132, Italy

Okehazama HospitalRecruiting

Toyoake, Aichi-ken 470-1168, Japan

Local Institution - 0205Not yet recruiting

Ichikawa, Chiba 272-8516, Japan

Local Institution - 0172Withdrawn

Iizuka, Fukuoka 820-8505, Japan

Local Institution - 0141Withdrawn

Kitakyushu-shi, Fukuoka 8078555, Japan

Goryokai Medical Corporation - Goryokai HospitalRecruiting

Sapporo, Hokkaido 002-8029, Japan

Local Institution - 0107Not yet recruiting

Yokohama, Kanagawa 234-0051, Japan

Rainbow and Sea HospitalRecruiting

Karatsu, Saga-ken 847-0031, Japan

Juntendo University HospitalRecruiting

Bunkyo-ku, Tokyo 113-8431, Japan

Tadafumi Kato, Site 0180Contact

+81-(0)3-3813-3111

Nippon Medical School HospitalRecruiting

Bunkyo-ku, Tokyo 1138603, Japan

Amane Tateno, Site 0139Contact

+81-3-3822-2131

Local Institution - 0201Not yet recruiting

Kodaira, Tokyo 187-8551, Japan

Narimasu Kosei HospitalRecruiting

tabashi City, Tokyo 175-0091, Japan

Kuramitsu HospitalRecruiting

Fukuoka, 819-0037, Japan

Kochi Health Sciences CenterRecruiting

Kochi, 781-8555, Japan

Instytut Psychiatrii i NeurologiiRecruiting

Warsaw, Masovian Voivodeship 02-957, Poland

Uniwersyteckie Centrum KliniczneRecruiting

Gdansk, Pomeranian Voivodeship 80-214, Poland

Local Institution - 0103Not yet recruiting

Rybnik, Silesian Voivodeship 44-200, Poland

Clinica InventivaRecruiting

Tuszyn, 95-080, Poland

Local Institution - 0093Not yet recruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"Recruiting

Bucharest, 011241, Romania

Local Institution - 0099Not yet recruiting

Bucharest, 0, Romania

Local Institution - 0203Not yet recruiting

Bucharest, 41914, Romania

Local Institution - 0097Not yet recruiting

Iași, 700282, Romania

Spitalul de Psihiatrie și Neurologie BrașovRecruiting

Sanpetru /Brasov, 507190, Romania

Petru Ifteni, Site 0095Contact

0040724993329

Local Institution - 0101Not yet recruiting

Sibiu, 550082, Romania

Local Institution - 0167Not yet recruiting

Smila, Cherkasy Oblast 20708, Ukraine

Local Institution - 0165Not yet recruiting

Dnipro, Dnipropetrovsk Oblast 49005, Ukraine

Local Institution - 0178Not yet recruiting

Skarzhyntsi, Khmelnytskyi Oblast 32120, Ukraine

Site 0178Contact

Local Institution - 0163Not yet recruiting

Nove, Kirovohrad Oblast 25491, Ukraine

Local Institution - 0169Not yet recruiting

Hlevakha, Kyivska Oblast 08631, Ukraine

Local Institution - 0162Not yet recruiting

Kyiv, Kyivska Oblast 04080, Ukraine

Local Institution - 0164Not yet recruiting

Lviv, Lviv Oblast 79021, Ukraine

Local Institution - 0170Not yet recruiting

Odesa, Odesa Oblast 67513, Ukraine

Local Institution - 0168Not yet recruiting

Vinnytsia, Vinnytsia Oblast 21037, Ukraine

Local Institution - 0171Not yet recruiting

Odesa, 65006, Ukraine

Local Institution - 0177Not yet recruiting

Poltava, 36000, Ukraine

Local Institution - 0206Not yet recruiting

Ternopil, 46027, Ukraine