A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •21 to 85 Years of age
- •Diagnosis of Stage I, II or III cancer
- •Histologically-proven malignancy
- •Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy
- •Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms)
- •Duration of depressive symptoms ≥ 2 weeks by patient report.
- •No active/acute suicidality requiring immediate care or psychiatric hospitalization
- •Sufficient English language proficiency to complete all assessments without assistance
- •Able to swallow pills
- •No severe anemia, defined as hemoglobin < 10 g/dL
- •No history of multiple adverse drug reactions or allergy to study drugs
- •Not pregnant
- •No history of head trauma
- •No history of epilepsy
- •No other concurrent antidepressant medications
排除标准
- •Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus).
- •Have a documented history of an intellectual disability.
- •Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
- •Currently being treated with tamoxifen.
- •Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.
- •Have a history of any seizure disorder.
- •Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.
- •Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:
- •A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or
- •A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.
- •Have a history of substance dependence/abuse** within the past 6 months or a positive drug screen result during the screening period.
- •Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
- •* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day.
- •** Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded.
研究组 & 干预措施
1 PDC-1421 Capsule
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
干预措施: PDC-1421 Capsule (Drug)
2 PDC-1421 Capsules
2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
干预措施: PDC-1421 Capsule (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 5 weeks
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1, 2, 3, 4, and 5 in patients taking 1 or 2 PDC-1421 capsules. The MADRS is a 10-item checklist including 1) depression \[apparent\]; 2) depression \[reported\]; 3) loss of interest; 4) suicidal ideation; 5) tension; 6) reduced appetite; 7) insomnia; 8) difficulty in activities; 9) concentration; and 10) pessimism. The MADRS is administered by a trained interviewer. Each item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 \[extremely despondent\]). The total score is used to define treatment response (≥50% reduction from baseline) and partial response (20-49% reduction from baseline). Remission is defined as a score of \< 10. The following are used as an interpretation of scores: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
次要结局
未报告次要终点