Trial · Interventional
RecruitingPhase 4Registry dataEfficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 250 participants (estimated)
- Sponsor
- Valenta Pharm JSC · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Russia
- Start
- 13 Jan 2025
- Primary completion
- 31 Dec 2027 (estimated)
- Completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2025
- Last update posted
- 8 Jul 2025
- Conditions
- Anxiety · Neurasthenia · Adjustment Disorders
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
NCT0684304413 Jan 2025 to est. 31 Dec 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg/day compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg/day for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.
Interventions
- RanquilonDrug
- AfobazoleDrug
Arms2
Experimental
Ranquilon, 6 mg/day
Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days
Active comparator
Afobazole, 30 mg/day
Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days
Primary outcomes1
Outcomes the sponsor listed as primary.
The proportion of patients with a significant reduction in anxiety levels (by 50% or more) on Hamilton Anxiety Rating Scale (HARS) compared to baseline on Day 29 ± 1 (Visit 3)
Time frame · Day 29 ± 1 (Visit 3)
Registry description
HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations.
Secondary outcomes(20)
Change in anxiety levels according to the Hamilton Anxiety Rating Scale (HARS) scale on Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations.
Proportion of patients with a reduction in anxiety levels on the Hamilton Anxiety Rating Scale (HARS) scale to 17 points or less on Day 29 ± 1 (Visit 3)
Time frame · Day 29 ± 1 (Visit 3)
Registry description
HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations.
Proportion of patients with a score of 2 points or less on the Clinical Global Impression (CGI-s) scale as assessed by the physician (healthy or borderline disorder) on Day 29 ± 1 (Visit 3)
Time frame · Day 29 ± 1 (Visit 3)
Registry description
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
Change in the severity of the patient's condition on the Clinical Global Impression (CGI-s) scale by Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
Change in the total score on the Multidimensional Fatigue Inventory (MFI-20) on Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible).
Proportion of patients with a reduction in total score on the Multidimensional Fatigue Inventory (MFI-20) by 25% on Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible).
Proportion of patients with a reduction in total score on the Multidimensional Fatigue Inventory (MFI-20) by 50% on Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible).
Proportion of patients with a total score on the Multidimensional Fatigue Inventory (MFI-20) reduced to 30 points or less on Day 29 ± 1 (Visit 3)
Time frame · Day 29 ± 1 (Visit 3)
Registry description
Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible).
Absolute value of the patient's self-assessment of their subjective condition for all individual items on the Multidimensional Fatigue Inventory (MFI-20) scale by Day 29 ± 1 (Visit 3)
Time frame · Day 29 ± 1 (Visit 3)
Registry description
Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible).
Change in total score on the Columbia-Suicide Severity Rating Scale (C-SSRS) by Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
A severity rating of "3" or higher indicates a serious risk of suicide. A rating of "5" and any identified suicidal actions indicate an extremely high risk and an absolute necessity for urgent therapeutic measures and hospitalization. The section "intensity of suicidal thoughts" allows for a more accurate assessment of severity and prediction of its dynamics.
Change in total score on the Emotional Eating Questionnaire by Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
The scale ranges from 0 to 30 points, where a minimum indicates no emotional overeating and a maximum indicates a strong dependence of eating behavior on emotional state.
Change in total score on the Psychological Stress Measure (PSM-25) by Day 29 ± 1 (Visit 3) compared to baseline
Time frame · Day 29 ± 1 (Visit 3)
Registry description
A score below 99 indicates low stress, a score between 100-125 indicates moderate stress; a score above 125 indicates high stress
Safety and Tolerability: adverse event (AE) rate
Time frame · 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 43 ± 1 for each participant
Registry description
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Safety and Tolerability: AEs associated with the study drug
Time frame · 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 43 ± 1 for each participant
Registry description
Number and frequency of AEs or SAEs associated with the study drug
Safety and Tolerability: treatment discontinuation
Time frame · 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 43 ± 1 for each participant
Registry description
Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
Time frame · Screening, day 1, day 29 ± 1, day 43 ± 1
Registry description
SBP, mmHg
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
Time frame · Screening, day 1, day 29 ± 1, day 43 ± 1
Registry description
DBP, mmHg
Safety and Tolerability: vital signs - respiratory rate (RR)
Time frame · Screening, day 1, day 29 ± 1, day 43 ± 1
Registry description
RR, breaths per minute
Safety and Tolerability: vital signs - heart rate (HR)
Time frame · Screening, day 1, day 29 ± 1, day 43 ± 1
Registry description
HR, beats per minute
Safety and Tolerability: vital signs - body temperature
Time frame · Screening, day 1, day 29 ± 1, day 43 ± 1
Registry description
Body temperature, Celsius scale
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
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Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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