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Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders

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

NCT06843044•Valenta Pharm JSC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged 18 to 70 years;
•2. Written informed consent form in accordance with current legislation;
•3. Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);
•4. Anxiety severity on the HARS scale of 18-24 points;
•5. Assessment of the severity of suicidal thoughts using the Columbia scale \<3 points;
•6. Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points;
•7. Total score on the Hamilton Depression Rating Scale (HAMD-17) \< 6;
•8. Score on the CGI-s scale of at least 4 points;
•9. Negative pregnancy test for women of childbearing potential;
•10. Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men);
+31 more criteria

Exclusion Criteria

•1. The patient's decision to withdraw from the study (revocation of informed consent);
•2. 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;
•3. The investigator's decision that the patient needs to be excluded in the best interest of the patient;
•4. The patient refuses to cooperate with the investigator or is non-compliant;
•5. Emergence of reasons/situations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
•7. Significant violation of the treatment regimen.
•A significant violation is considered:
•1. Missing doses of the study drugs for 2 consecutive days or more, or
•2. 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).
•8. Positive pregnancy test;
+6 more criteria

Locations (6)

Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region

Engel's, Russia

Unimed-C Jsc

Moscow, Russia

Aurora MedFort LLC

Saint Petersburg, Russia

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Russia

Limited Liability Company "Stepmed Clinic"

Saint Petersburg, Russia

Saratov City Psychoneurological Dispensary

Saratov, Russia

Key Dates

Start Date

January 13, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

July 8, 2025

Enrollment

250

ESTIMATED participants

Conditions

AnxietyNeurastheniaAdjustment Disorders

Interventions

Ranquilon

DRUG

Afobazole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders

Inclusion Criteria

Exclusion Criteria

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