Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Recruiting now · Phase 4
Conditions studied: Anxiety, Neurasthenia, Adjustment Disorders
In brief
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.
Key facts
- Study ID
- NCT06843044
- Run by
- Valenta Pharm JSC
- People needed
- 250
- Starts
- 2025-01-13
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-07-08
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- 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);
You may not qualify if…
- 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;
- 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.
Where it is running
- Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region — Engel's, Russia (enrolling)
- Unimed-C Jsc — Moscow, Russia (enrolling)
- Aurora MedFort LLC — Saint Petersburg, Russia (enrolling)
- Limited Liability Company "Research Center Eco-Safety" — Saint Petersburg, Russia (enrolling)
- Limited Liability Company "Stepmed Clinic" — Saint Petersburg, Russia (enrolling)
- Saratov City Psychoneurological Dispensary — Saratov, Russia (enrolling)
Full record on ClinicalTrials.gov
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