Идёт набор NCT07220460

Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

Фаза II С лечением Bipolar I or II Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ABBV-932.
Кому может быть актуально: Состояния в реестре: Bipolar I or II Disorder. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Пуэрто-Рико
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder

Обзор

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

Препарат ABBV-932
Oral Capsule

Первичные конечные точки

Number of Participants Experiencing Adverse Events [Срок оценки: Up to approximately 29 weeks]
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Срок оценки: Up to week 26]
Number of Participants with Change from Baseline in Electrocardiogram (ECG) [Срок оценки: Up to week 26]
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Срок оценки: Up to week 26]
Change From Baseline in Simpson-Angus Scale (SAS) [Срок оценки: Up to week 26]
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [Срок оценки: Up to week 26]
Change From Baseline in Barnes Akathisia Rating Scale (BARS) [Срок оценки: Up to week 26]
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to week 26]
Change From Baseline in the Epworth Sleepiness Scale (ESS) [Срок оценки: Up to week 26]
Change From Baseline in the Young Mania Rating Scale (YMRS) [Срок оценки: Up to week 26]

Критерии участия

Критерии включения

Body Mass Index (BMI) >= 18.0 to <= 40.0 kg/m\^2, inclusive.
Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
Participant with the following psychiatric history:

No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 months prior to Screening.

Критерии исключения

A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (e.g., participants with eGFR < 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет