An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Roll-over participants:
- •Provide written informed consent before the initiation of any study specific procedures
- •Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- •Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males
- •Ability to follow study instructions and likely to complete all required visits
- •In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
- •If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study
- •Inclusion criteria for De-novo participants:
- •Provide written informed consent before the initiation of any study-specific procedures
- •Male or female participants greater than or equal to (>=) 18 years of age
- •Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m^2), inclusive
- •At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed by the investigator or sponsor-approved rater using the structured clinical interview for DSM-5, clinical trials version (SCID 5-CT)
- •Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
排除标准
- •for Roll-over participants
- •In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores >= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator
- •The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
- •Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study
- •The participant has any other condition that may be detrimental to the participant if they participate in the study
- •In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study
- •Exclusion criteria for De-novo participants
- •Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
- •Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)
- •MADRS total score greater than (>) 18 at screening or baseline
- •The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time
- •The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients
研究组 & 干预措施
ITI-1284
Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 [NCT06480383] and Study ITI-1284-302 [NCT06701903]) ("roll-over participants") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks.
干预措施: ITI-1284 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Week 52
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
次要结局
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline up to Week 52)
- Change from Baseline in Clinical Global Impression-Severity (CGI S) Score(Baseline up to Week 52)