2024-513019-29-00招募中3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Compare the Anti-Depressive Efficacy and Safety of Samyr® Tablet versus Placebo Tablet on top of Adjunctive Antidepressant Treatment in Patients with Major Depression Disorder with Mild to Moderate Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mylan Inc.
- 入组人数
- 600
- 试验地点
- 14
- 主要终点
- The primary endpoint is the change from baseline in the HDRS-17 score to visit 9 (Week 6).
研究概览
简要总结
To demonstrate that in subjects with MDD with inadequate response to antidepressants and Hamilton score of 15-20 (with up to 10% reduction at baseline) Samyr® is superior to placebo tablet, when used along with an adjunctive antidepressant therapy following six weeks of treatment based on HDRS-17 score.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written and signed informed consent needs to be provided by subject before starting any protocol-specific procedures.
- •Male and female subject between the ages of 18 to 65 years, both ages inclusive.
- •Subject who is able and willing to comply with the requirements of the study protocol including the visits scheme, assessments and scales.
- •Primary diagnosis of MDD of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and as confirmed by version 7.0 of the Mini International Neuropsychiatric Interview (MINI).
- •Subject is on prescribed SSRI (citalopram / escitalopram / sertraline / paroxetine / fluoxetine) or SNRI (venlafaxine / desvenlafaxine / duloxetine) antidepressant treatment, at approved and stable dose, for at least 4 weeks prior to screening that is insufficient/ineffective.
- •The subject is deemed to have inadequate response (less than 50% symptom reduction) to their current antidepressant based on the investigator judgment and the treatment history.
- •Subject who have a HDRS-17 score between 15-20 at screening. The baseline score must remain ≤20 and should not have >10% reduction between screening and baseline (randomization visit).
排除标准
- •History or presence of a medical condition or disease that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation.
- •Hypersensitivity to the active substance or to any of the excipients of Samyr or placebo (lactose).
- •Subjects with known genetic defects which affect the methionine cycle and/or cause homocystinuria and/or hyperhomocysteinaemia (e.g. cystathionine beta-synthase deficiency, defects of vitamin B12 metabolism).
- •Treatment with Monoamine Oxidase (MAO)-inhibitors including selegiline and moclobemide, during the 4 weeks prior to screening.
- •Treatment with linezolid or pimozide during the 4 weeks prior to screening; these must not be taken during study.
- •Treatment with prohibit medication prior to screening as detailed in Appendix
- •Cardiac disorder which in the Investigator’s opinion would place the subject at an unacceptable risk from trial participation.
- •Known QT interval prolongation or congenital long QT syndrome.
- •Currently treatment with products that are known to prolong the QT interval.
- •Hepatic values that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation.
- •Female subjects who are pregnant or breast-feeding or are planning to become pregnant during the study.
- •Any clinically significant abnormality in electrocardiogram (ECG) or safety laboratory tests that in the Investigator’s opinion would place the subject at an unacceptable risk as a result of trial participation.
- •Female subjects of childbearing potential who are not able/willing to use oral contraception or acceptable methods of contraception as outlined in this protocol (Protocol Section 4.3), from the time of screening and for the duration of the study, through study completion.
- •Receipt of another investigational drug within 45 days prior to screening, or if the screening visit is within 5 half-lives of another investigational drug received (whichever is longer) or scheduled to receive another investigational drug during the current study period.
- •Any elective surgery requiring hospitalization planned during the study period.
- •Any lifetime history of bipolar disorders or psychotic disorders (other than MDD with psychotic features in a prior but not the current episode) as per the MINI.
- •History of drug abuse and/or marijuana use and/or alcohol dependence during the 3 years prior to screening.
- •The subject is, in the investigator’s opinion, at significant current risk of harming himself/herself, or provides the following answers on the C-SSRS at screening: - “Yes” to Question 4 or 5 on the Lifetime version Suicidal Ideation section and the ideation was within the last 3 months at Screening Visit, OR - “Yes” to question on the Lifetime version Suicidal Behavior section (other than preparatory behavior) and the ideation was within the last 3 months at Screening Visit.
- •Use of more than any 4 acceptable antidepressant treatments since the diagnosis of depression.
- •Previous treatment with Samyr which was not effective or resulted in an AE, or already treated with Samyr for the current episode.
结局指标
主要结局
The primary endpoint is the change from baseline in the HDRS-17 score to visit 9 (Week 6).
The primary endpoint is the change from baseline in the HDRS-17 score to visit 9 (Week 6).
次要结局
- Change from baseline of the PGI and CGI scales after 6 weeks of treatment (visit 9).
研究者
EUClinicalTrials@Viatris
Scientific
Mylan Inc.
研究点 (14)
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