A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
研究概览
简要总结
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants between 25 and 55 years of age (inclusive) at screening.
- •Are remitted from depression.
- •Have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression (e.g. cognitive behaviour therapy) for a previous MDE
- •Report present subjective cognitive impairment (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
- •Have not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to Screening Visit
- •Otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, haematologic assessments, and urinalysis, measurement of vital signs, and Electrocardiogram (ECG).
- •Negative serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.
- •Have a body mass index (BMI) of 18 to 36 inclusive.
- •Agree not to use herbal medications (including herbal tea, St. John's Wort), within 14 days prior to study agent administration through to the final follow-up visit.
- •Participants must be able and willing to give written, informed consent, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •The participant, in the opinion of the investigator, is willing and able to adhere to the study visit schedule and other requirements, prohibitions and restrictions of the study.
排除标准
- •They are left-handed.
- •Have immediate recall of greater than 22 words from the International Shopping List Test (ISLT) and have delayed recall of greater than 8 words from the ISLT 15 mins after the presentation of the word list.
- •Positive urine drug screen or alcohol breath test at screening or assessment visits.
- •History or presence of significant neurological or psychiatric conditions except those related to MDD.
- •Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at screening or baseline visit.
- •Has a known clinically relevant structural brain abnormality as determined by e.g. previous MRI, or, persistent MRI imaging artefact which is judged to produce extensive imaging distortions.
- •Has a disease or takes medication that could, in the investigator's and/or sponsor's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
研究组 & 干预措施
SDI-118 low dose
SDI-118 (low dose) orally once daily (QD) for 17±1 day.
干预措施: SDI-118 (Drug)
SDI-118 high dose
SDI-118 (high dose) orally once daily (QD) for 17±1 day.
干预措施: SDI-118 (Drug)
Placebo
Placebo orally once daily (QD) for 17±1 day.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant ECG values
Number of participants with Adverse Events (AEs)
时间窗: 17 days
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in the COWAT values.
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in C-SSRS values.
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in the CFT values.
Number of participants with vital sign abnormalities and/or adverse events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant vital sign values
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in physical examination.
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
时间窗: 17 days
Number of participants with potentially clinically significant changes in the DSST values.
次要结局
- Performance measures associated with executive function (working memory) during the N-Back Tasks(17 days)
- Changes in Blood Oxygen Level Dependent (BOLD) signal(17 days)