A Phase 4 interventional study of Ranquilon and Afobazole in Anxiety, Neurasthenia and Adjustment Disorders, sponsored by Valenta Pharm JSC. Recruiting at 6 sites in Russia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Valenta Pharm JSC · Phase 4, Interventional, and Treatment
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inclusion Criteria:
Exclusion Criteria:
Significant violation of the treatment regimen.
A significant violation is considered:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days
Drug: Ranquilon
Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days
Drug: Afobazole
1 mg tablets
Also known as: GB-115, N-(6-phenylhexanoyl)glycyl-L-tryptophan amide
10 mg tablets
Also known as: Fabomotizole
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.
Time frame: Day 29 ± 1 (Visit 3)
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.
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)
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.
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)
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
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
The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder.
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
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).
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
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).
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
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).
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)
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).
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)
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).
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
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.
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
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.
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
A score below 99 indicates low stress, a score between 100-125 indicates moderate stress; a score above 125 indicates high stress
Time frame: Day 29 ± 1 (Visit 3)
Safety and Tolerability: adverse event (AE) rate
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
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
Number and frequency of AEs or SAEs 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
Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
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)
SBP, mmHg
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
DBP, mmHg
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - respiratory rate (RR)
RR, breaths per minute
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - heart rate (HR)
HR, beats per minute
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: vital signs - body temperature
Body temperature, Celsius scale
Time frame: Screening, day 1, day 29 ± 1, day 43 ± 1
Safety and Tolerability: concomitant treatment
Data on concomitant treatment (if any)
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
Hemoglobin (g/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - hematocrit
Hematocrit (%)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - red blood cell count
Red blood cell count (cells/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - platelet count
Platelet count (cells/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - leukocyte count
Leukocyte count (cells/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm/h)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - myelocytes
Leukocyte formula (myelocytes, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - band neutrophils
Leukocyte formula (band neutrophils, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - segmented neutrophils
Leukocyte formula (eosinophils, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - basophils
Leukocyte formula (basophils, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - monocytes
Leukocyte formula (monocytes, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: clinical blood test - lymphocytes
Leukocyte formula (lymphocytes, %)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - color
Color of the urine
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - pH
pH of the urine
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - protein
Protein concentration (g/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - glucose
Glucose concentration (mmol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - red blood cells
Red blood cell content (number in sight)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - white blood cells
White blood cell content (number in sight)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - epithelial cells
Epithelial cell content (number in sight)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - ketone bodies
Ketone bodies (mmol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: urinalysis - urobilinogen
Urobilinogen (mcmol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - glucose
Glucose concentration (mmol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - cholesterol
Total cholesterol concentration (mmol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - protein
Total protein concentration (g/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - bilirubin
Total bilirubin concentration (micromol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - creatinine
Creatinine concentration (micromol/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - alkaline phosphatase
Alkaline phosphatase activity (U/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - alanine transaminase
Alanine transaminase activity (U/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - aspartate transaminase
Aspartate transaminase activity (U/L)
Time frame: Screening, day 29 ± 1
Safety and Tolerability: blood chemistry - urea
Urea concentration (mmol/L)
Time frame: Screening, day 29 ± 1
Plan to share: No
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