AnxietyPhase 4NCT06843044
Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
A Phase 4 study testing Ranquilon and Afobazole in people with Anxiety and Neurasthenia, run by Valenta Pharm JSC at 6 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety, Neurasthenia, Adjustment Disorders
- What is being tested?
- Ranquilon and Afobazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 6 sitesRussia
- Study dates
- 13 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 70 years;
- Written informed consent form in accordance with current legislation;
- Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);
- Anxiety severity on the HARS scale of 18-24 points;
- Assessment of the severity of suicidal thoughts using the Columbia scale <3 points;
- Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points;
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- Total score on the Hamilton Depression Rating Scale (HAMD-17) < 6;
- Score on the CGI-s scale of at least 4 points;
- Negative pregnancy test for women of childbearing potential;
- Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men);
- Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of health-related information), and comply with the procedures outlined in the study protocol.
- Non-inclusion Criteria:
- Known intolerance to the active and/or excipient substances contained in the study drugs;
- Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance;
- Patients requiring prohibited concomitant therapy within this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), hypnotics when used on a regular basis), or who have taken these medications within the last month;
- Established or suspected alcohol/narcotic substance use at the time of screening or randomization, and/or a history of alcohol, narcotic, or drug dependence;
- Presence of oncological diseases, including in history (except for cured tumors with stable remission for more than 5 years);
- Tuberculosis, including in history;
- Presence of HIV, chronic viral hepatitis B/C, syphilis (including past history), or a positive test for HIV, hepatitis B/C, or syphilis at screening;
- Patients with a diagnosis of other anxiety disorders (F41) established based on ICD-10 criteria;
- Schizophrenia, schizoaffective disorders, affective disorders, and panic disorders;
- Acute psychosis (endogenous-processual, organic, or somatogenic), including in history;
- Organic lesions of the central nervous system of traumatic and alcoholic origin;
- Post-encephalitic syndrome;
- History of brain tumors (including past diagnoses);
- Degenerative diseases of the central nervous system (CNS), particularly multiple sclerosis;
- History of depression (including past episodes);
- Suicide attempts in history;
- Generalized anxiety disorder, including in history;
- History of epilepsy and seizures (including past episodes);
- Decompensated diabetes mellitus;
- Established diagnosis of chronic kidney disease stage 3A and above, or estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault formula ≤ 59 ml/min/1.73 m²;
- Established diagnosis of liver failure of any severity, or elevated levels of ALT, AST or total bilirubin >3 times the upper limit of normal according to laboratory standards;
- History of major surgical interventions within six months prior to screening;
- Chronic heart failure III-IV functional class according to the New York Heart Association (NYHA) classification;
- Severe, decompensated, or unstable diseases (any diseases or conditions that poses a life-threatening risk to the patient, worsens the patient's prognosis, or makes participation in the clinical study impossible);
- Pregnant women, breastfeeding women, or women planning to become pregnant during the study or within 30 days after participation ends;
- Refusal by the patient to use permitted methods of contraception or to completely abstain from sexual contact throughout the entire period of participation in the study starting from Visit 0 and for 30 days after completion of participation;
- Current participation or planned participation by the patient in psychological or psychotherapeutic activities aimed at treating anxiety disorder during the clinical trial period;
- Participation in any other clinical trial within 90 days prior to the start of the screening period;
- Lack of patient cooperation;
- Other reasons, at the investigator's discretion, that may hinder the patient's participation in the study or pose unjustified risk to the patient.
Who cannot join
- The patient's decision to withdraw from the study (revocation of informed consent);
- Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;
- The investigator's decision that the patient needs to be excluded in the best interest of the patient;
- The patient refuses to cooperate with the investigator or is non-compliant;
- Emergence of reasons/situations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
- Inclusion of a patient in the study that does not meet the inclusion/exclusion criteria, including cases of deviation from normal values in laboratory test results obtained at Visit 0;
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- Significant violation of the treatment regimen.
- A significant violation is considered:
- Missing doses of the study drugs for 2 consecutive days or more, or
- Taking a total number of tablets < 80% or > 120% of the full course (the full course for Ranquilon is 168 tablets, and for Afobazole, it is 84 tablets).
- Positive pregnancy test;
- Confirmed diagnosis of COVID-19;
- Emergence of other reasons during the study that prevent its conduct according to the protocol;
- Patient death;
- Sponsor-initiated study termination;
- Termination of the study by the Investigator;
- Termination of the study by regulatory authorities.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Russia6 sites, 6 recruiting
- Recruiting
Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region
Engel's, 413090
Alexey Kokoshnikov, MD, +7-8453-552633, kokoshnikoff@mail.ru
- Recruiting
Unimed-C Jsc
Moscow, 119571
Elena Volnaya, MD, +7-495-135-50-10, drvolnaya@yandex.ru
- Recruiting
Aurora MedFort LLC
Saint Petersburg, 194156
Igor Balaban, MD, +7-921-903-94-95, igorbalaban.81@mail.ru
- Recruiting
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
Maxim M Gavrik, MD, +7-812-735-96-98, polniy_maximus@mail.ru
- Recruiting
Limited Liability Company "Stepmed Clinic"
Saint Petersburg
Oleg Goncharov, MD, PhD, +7-812-3375800, ovg2804@gmail.com
- Recruiting
Saratov City Psychoneurological Dispensary
Saratov, 410038
Yuriy Filimonov, MD, +7-8452-752797, yuriyfilimonov555@gmail.com
About this study
Official title: An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
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.
- Conditions
- Anxiety, Neurasthenia, Adjustment Disorders
- Being tested
- Ranquilon, Afobazole
- Medical subject headings
- Anxiety Disorders, Neurasthenia, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanquilonDrug
Also called GB-115, N-(6-phenylhexanoyl)glycyl-L-tryptophan amide
1 mg tablets
AfobazoleDrug
Also called Fabomotizole
10 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Ranquilon, 6 mg/day | Experimental | Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days Receives: Drug: Ranquilon |
| Afobazole, 30 mg/day | Active comparator | Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days Receives: Drug: Afobazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Day 29 ± 1 (Visit 3)
Secondary outcomes (53)
Change in anxiety levels according to the Hamilton Anxiety Rating Scale (HARS) scale on Day 29 ± 1 (Visit 3) compared to baseline
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.
Measured: Day 29 ± 1 (Visit 3)
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)
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.
Measured: Day 29 ± 1 (Visit 3)
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)
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
Measured: Day 29 ± 1 (Visit 3)
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
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
Measured: Day 29 ± 1 (Visit 3)
Change in the total score on the Multidimensional Fatigue Inventory (MFI-20) on Day 29 ± 1 (Visit 3) compared to baseline
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).
Measured: Day 29 ± 1 (Visit 3)
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
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).
Measured: Day 29 ± 1 (Visit 3)
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
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).
Measured: Day 29 ± 1 (Visit 3)
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)
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).
Measured: Day 29 ± 1 (Visit 3)
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)
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).
Measured: Day 29 ± 1 (Visit 3)
Change in total score on the Columbia-Suicide Severity Rating Scale (C-SSRS) by Day 29 ± 1 (Visit 3) compared to baseline
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.
Measured: Day 29 ± 1 (Visit 3)
Change in total score on the Emotional Eating Questionnaire by Day 29 ± 1 (Visit 3) compared to baseline
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.
Measured: Day 29 ± 1 (Visit 3)
Change in total score on the Psychological Stress Measure (PSM-25) by Day 29 ± 1 (Visit 3) compared to baseline
A score below 99 indicates low stress, a score between 100-125 indicates moderate stress; a score above 125 indicates high stress
Measured: Day 29 ± 1 (Visit 3)
Safety and Tolerability: adverse event (AE) rate
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: 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
Safety and Tolerability: AEs associated with the study drug
Number and frequency of AEs or SAEs associated with the study drug
Measured: 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
Safety and Tolerability: treatment discontinuation
Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
Measured: 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
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
SBP, mmHg
Measured: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
DBP, mmHg
Measured: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - respiratory rate (RR)
RR, breaths per minute
Measured: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - heart rate (HR)
HR, beats per minute
Measured: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - body temperature
Body temperature, Celsius scale
Measured: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: concomitant treatment
Data on concomitant treatment (if any)
Measured: 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
Safety and Tolerability: clinical blood test - hemoglobin
Hemoglobin (g/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - hematocrit
Hematocrit (%)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (eosinophils, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - color
Color of the urine
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - epithelial cells
Epithelial cell content (number in sight)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - ketone bodies
Ketone bodies (mmol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - urobilinogen
Urobilinogen (mcmol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - protein
Total protein concentration (g/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Measured: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - urea
Urea concentration (mmol/L)
Measured: Screening, day 29 ± 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start13 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843044
- Sponsor's protocol ID
- RAN-04-05-2024
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
- ClinicalTrials.gov ID
- NCT06843044
- Acronym / sponsor ID
- RAN-04-05-2024
- Conditions
- Anxiety, Neurasthenia, Adjustment Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranquilon, 6 mg/day | Experimental | Drug: RanquilonRanquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days |
| Afobazole, 30 mg/day | Active comparator | Drug: AfobazoleAfobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Males and females aged 18 to 70 years;
- Written informed consent form in accordance with current legislation;
- Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);
- Anxiety severity on the HARS scale of 18-24 points;
- Assessment of the severity of suicidal thoughts using the Columbia scale <3 points;
Key exclusion criteria (17 listed)
- The patient's decision to withdraw from the study (revocation of informed consent);
- Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;
- The investigator's decision that the patient needs to be excluded in the best interest of the patient;
- The patient refuses to cooperate with the investigator or is non-compliant;
- Emergence of reasons/situations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanquilonAlso: GB-115, N-(6-phenylhexanoyl)glycyl-L-tryptophan amide1 mg tablets | Drug | Ranquilon, 6 mg/day |
| AfobazoleAlso: Fabomotizole10 mg tablets | Drug | Afobazole, 30 mg/day |
Primary outcome
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)
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.
53 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - respiratory rate (RR)
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - heart rate (HR)
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - body temperature
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: concomitant treatment
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
Safety and Tolerability: clinical blood test - hemoglobin
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - hematocrit
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - red blood cell count
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - platelet count
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - leukocyte count
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - myelocytes
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - band neutrophils
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - segmented neutrophils
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - basophils
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - monocytes
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - lymphocytes
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - specific gravity
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - color
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - transparency
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - pH
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - protein
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - glucose
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - red blood cells
Time frame: Screening, day 29 ± 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region
Engel's, Russia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranquilon and Afobazole in people with Anxiety and Neurasthenia, run by Valenta Pharm JSC at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.