NCT05586789已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Phase III Clinical Trial to Examine the Clinical Efficacy and Safety of Ranquilon, 1 mg Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 10
- 主要终点
- Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder.
An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 70
- •Presence of written consent to participate in the study in accordance with applicable law
- •Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2)
- •HARS anxiety scores of 18-24
- •Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50 points
- •Hamilton Depression Assessment Scale (HAMD-17) score < 6
- •CGI-s scale score of at least 4
- •Negative pregnancy test for women of preserved reproductive potential
- •Consent to use effective contraception for the duration of the study and 30 days after completion (for women of unresolved reproductive potential and men)
- •Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol
排除标准
- •Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
- •Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
- •Patients who require concomitant therapy prohibited in this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleeping pills when used on a continuous basis), or have taken these drugs within the last month
- •Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
- •Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
- •Presence of tuberculosis, including a history of tuberculosis
- •The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or a positive test for HIV, hepatitis B/C, syphilis at screening
- •Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)
- •Schizophrenia, schizoaffective, affective and panic disorders
- •Acute psychosis (endogenous-procedural, organic or somatogenic), including history
- •Organic lesions of the central nervous system of traumatic and alcoholic genesis
- •Postencephalitic syndrome
- •Brain tumors, including in the anamnesis
- •Degenerative diseases of the central nervous system (CNS), in particular, multiple sclerosis
- •Depression, including a history of depression
- •Generalized anxiety disorder, including a history
- •Suicidal thoughts or ideas; a history of suicide attempts
- •Epilepsy, seizures, including a history of seizures
- •Diabetes mellitus at the stage of decompensation
- •Established diagnosis of chronic kidney disease stage 3A or higher, or glomerular filtration rate (GFR) calculated by the Cockcroft-Gault formula = 59 ml/min/1.73 m2 or less
- •Established diagnosis of hepatic failure of any severity, or elevated ALT, AST or total bilirubin, urea >3 times the upper limit of normal values
- •Conditions after major surgical interventions, if less than six months have elapsed since the intervention
- •Chronic heart failure New York Heart Association (NYHA) functional class III-IV
- •Severe, decompensated, or unstable disease (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible to perform a clinical trial in the patient)
- •Pregnant women, women breastfeeding, or women planning to become pregnant during the study and 30 days after study participation ends
- •Refusal by the patient to use approved contraception or to completely abstain from sexual intercourse during the entire period of study participation, beginning at Visit 0, and for 30 days after completion of study participation
- •Patient's current or planned participation in psychological or psychotherapeutic interventions designed to treat an anxiety disorder during the course of the clinical trial
- •Participation in any other clinical trial within 90 days prior to the screening period
- •Lack of willingness to cooperate on the part of the patient
- •Other reasons that, in the opinion of the investigator, prevent the patient from participating in the study or pose an unreasonable risk to the patient
- •Withdrawal Criteria:
- •Patient's desire to stop participating in the study (withdrawal of informed consent) Each patient has the right to stop participating in the study at any time without giving a reason. Withdrawal from the study will not affect the medical care provided to the patient in the future.
- •A decision by the research physician that the patient should be excluded is in the patient's own best interest
- •Patient refuses to cooperate with the investigator or is undisciplined
- •Causes/occurrence of situations during the study that threaten patient safety (e.g., hypersensitivity reactions, SAE, etc.)
- •Inclusion of a patient in the study with inclusion/inclusion criteria not met (prior to randomization)
- •Significant violation of the treatment regimen A significant violation is defined as a) skipping study drug/placebo for 2 consecutive full days or more, or b) taking, in total, < 80% or >120% of the full course (full course = 168 pills)
- •Positive pregnancy test
- •Confirmed diagnosis of COVID-19
- •Occurrence in the course of the study of other reasons that prevent the study according to the protocol
- •Death of a patient
研究组 & 干预措施
Ranquilon
Experimental
Study drug Ranquilon, tablets, 1 mg, 2 tablets 3 times a day (daily dose - 6 mg/day), daily, for 28 days
干预措施: Ranquilon (Drug)
Placebo
Placebo Comparator
Placebo, tablets, 2 tablets 3 times a day, daily, for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1
时间窗: Day 29 ± 1 of the study
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
次要结局
- Time to significant or marked improvement - achieving a score of 1 or 2 on the CGI-i scale(Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first)
- Proportion of patients with a CGI-s score of 1 or 2 as assessed by the physician (healthy or borderline disorder) on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)(Day 15 ± 1 and Day 29 ± 1 of the study)
- Change in HARS anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline(Day 15 ± 1 and Day 29 ± 1 of the study)
- Time to decrease the HARS anxiety level to a score of 17 or less(Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first)
- Proportion of patients with significant and marked improvement as assessed by the physician (Clinical Global Impression - improvement (CGI-i) score 1 or 2) at Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)(Day 15 ± 1 and Day 29 ± 1 of the study)
- Change in patient severity on the CGI-s scale by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline(Day 15 ± 1 and Day 29 ± 1 of the study)
- Proportion of patients with HARS anxiety scores reduced to 17 or less on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)(Day 15 ± 1 and Day 29 ± 1 of the study)
- Time to decrease in severity of condition to 2 points or to 1 point or CGI-s scale(Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first)
- Safety and Tolerability: adverse event (AE) rate(From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant)
- Safety and Tolerability: vital signs - systolic blood pressure (SBP)(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: vital signs - diastolic blood pressure (DBP)(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: vital signs - heart rate (HR)(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate(Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - total protein(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - glucose(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Proportion of patients with a significant, i.e., 50% or greater reduction in HARS anxiety level on Day 15 ± 1 (Visit 2)(Day 15 ± 1 of the study)
- Time to decrease the MFI-20 cumulative score to 30 points or less(Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first)
- Safety and Tolerability: complete blood count - hemoglobin(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - hematocrit(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - erythrocyte sedimentation rate(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - eosinophils(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - basophils(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - total bilirubin(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - direct bilirubin(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - protein(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Absolute value of the patient's CGI-i score by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3)(Day 15 ± 1 and Day 29 ± 1 of the study)
- Proportion of patients with a 25% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline(Day 15 ± 1 and Day 29 ± 1)
- Proportion of patients with a 50% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline(Day 15 ± 1 and Day 29 ± 1)
- Safety and Tolerability: vital signs - respiratory rate (RR)(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: vital signs - body temperature(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - white blood cells(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - platelets(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - lymphocytes(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Change in the Multidimensional Fatigue Fatigue Inventory (MFI-20) total score on Day 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline(Day 15 ± 1 and Day 29 ± 1 of the study)
- Change in Spielberger personality anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline(Day 15 ± 1 and Day 29 ± 1)
- Safety and Tolerability: AEs associated with the study drug(From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant)
- Safety and Tolerability: treatment discontinuation(From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant)
- Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex(Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: physical examination results(Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval(Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - monocytes(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - alanine transaminase (ALT)(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - aspartate transaminase (AST)(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Time to decrease the MFI-20 cumulative score by 25% and 50% from baseline(Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first)
- Proportion of patients with a decrease in their MFI-20 cumulative score to 30 on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)(Day 15 ± 1 and Day 29 ± 1)
- Change in situational anxiety levels on the Spielberger questionnaire on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline(Day 15 ± 1 and Day 29 ± 1)
- Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)(Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - red blood cells(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - alkaline phosphatase (ALP)(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - urea(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - creatinine(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - pH(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - glucose(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - urobilinogen(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: complete blood count - neutrophils(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: blood test results - total cholesterol(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - color(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - transparency(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - specific gravity(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
- Safety and Tolerability: urinalysis - ketones(Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation)
研究者
研究点 (10)
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