A Phase 2a Study to Evaluate the Safety, Tolerability and Initial Efficacy of Pramipexole IR, Given With Ondansetron in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole
研究概览
简要总结
This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).
详细描述
This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).
Subjects will sign consent form prior to any study related procedure and will complete screening assessments. Subjects will be randomized to either the treatment group or the placebo group at a ratio of 1:1.
The study will be conducted in two parts. Titration period On Day 1, subjects will complete all baseline assessments prior to the 1st dosing.
Pramipexole group: Consenting individuals meeting accession criteria will start pramipexole 2.0mg daily dose (1.0mg twice a day) with ondansetron 16mg daily dose (8mg twice a day). Pramipexole will be titrated up daily or every two days depends on each patients' tolerability up to the first intolerable dose (FID) or maximum allowed dose (5 mg/day) according to titration schedule (Table 1). Once subjects reach their FID, their maximum allowed dose (MTD) will be defined as 1 mg below their FID.
During titration, subjects will be admitted to the clinic (subjects will be discharged on the day following their pramipexole FID or Day 8 if subjects reach to 5 mg/day of pramipexole.
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
- Double (Participant, Outcomes Assessor)
盲法说明
placebo
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Population: Males and females with a diagnosis of major depressive disorder
- •Inclusion Criteria:
- •Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate eligibility of the study.
- •Males and females aged 18 and 65 years inclusive.
- •Meet DSM-V R criteria for major depression, single episode or recurrent episode, with or without melancholia and without psychotic features (296.21, 296.22, 296.23, 296.31, 296.32, or 296.33).
- •Had a total score of > 18 on the HAM-D (17-item version), and a score of > 2 on the depressed mood item of the HAM-D at the screening visit and at the baseline visit.
- •Patients who are currently not on any antidepressants or, Patients on antidepressants and agree to the appropriate washout period (certain antidepressants with prolonged effects (e.g., fluoxetine) may need longer than 2 weeks post-discontinuation to obtain relatively uncontaminated baseline evaluation).
- •Agreed not to start psychotherapy or behavior therapy during the trial. Patients currently on these types of therapy for at least 3 months are eligible for the study and could continue to receive therapy during the trial.
排除标准
- •Women who are pregnant, or lactating; or taking a low-estrogen "mini-pill" contraceptive.
- •Individuals who are currently taking either study medication (pramipexole and/or ondansetron).
- •Renal and hepatic dysfunction with:
- •Total Bilirubin: >1.5 x UNL
- •AST: >2.5 x UNL
- •ALT: >2.5 x UNL
- •Serum Creatinine: >1.5 x UNL
- •Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation)
- •Hypersensitivity to any component of either study medication.
- •Lifetime history of hypomania/mania, psychotic disorder, dementia and borderline or antisocial personality disorders.
- •History of a serious suicidal attempt in the past 12 months; presence of serious suicidal tendencies/potential; modified C-SSRS >
- •Positive urine screen for benzodiazepines, cocaine/cocaine metabolites, cannabinoids, amphetamines, barbiturates, and opiates or history of moderate or severe substance dependence (drugs or alcohol, DSM-V-R criteria) within the past 6 months of the screening visit.
- •Non-responders to at least two trials of antidepressant treatment in the past. (Therapeutic dose for at least 6 weeks)
- •Patients currently taking or have taken the following medications within the past 6 months.
- •Centrally acting dopamine antagonists
- •Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- •Patients who have clinical significant hypotension or any clinical significant ECG abnormality at screening.
- •Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- •Patients who have participated in another clinical trial with an investigational drug within previous 30 days or 5 half-lives whichever is longer.
研究组 & 干预措施
treatment
CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily
干预措施: CTC-501 (Drug)
placebo
generic placebo tablets given orally twice daily
干预措施: CTC-501 (Drug)
结局指标
主要结局
Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole
时间窗: multiple over 8 weeks
All subjects will be assessed for dose limiting side effects such as nausea, vomiting and diarrhea.
次要结局
- Safety will be assessed by Incidence of Treatment-Emergent Adverse Events(Multiple over 8 weeks)
- The Montgomery-Åsberg Depression Rating Scale(Multiple over 7 weeks)
- Clinical Global Impression - Severity scale(Multiple over 7 weeks)
- Clinical Global Impression - Improvement scale(at week 8 only)
- Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron(Multiple over 7 weeks)