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

NCT06843044 | Recruiting Phase 4

• 1 other identifier: RAN-04-05-2024
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Anxiety; Neurasthenia; Adjustment Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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)

  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

  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

  Day 29 ± 1 (Visit 3)

Study Arms (2)

Ranquilon, 6 mg/day

EXPERIMENTAL

Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days

Drug: Ranquilon

Afobazole, 30 mg/day

ACTIVE COMPARATOR

Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days

Drug: Afobazole

Interventions

Ranquilon DRUG

1 mg tablets

Also known as: GB-115, N-(6-phenylhexanoyl)glycyl-L-tryptophan amide

Ranquilon, 6 mg/day

Afobazole DRUG

10 mg tablets

Also known as: Fabomotizole

Afobazole, 30 mg/day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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;

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.);
• 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;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (6)

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

Engel's, 413090, Russia

RECRUITING

Unimed-C Jsc

Moscow, 119571, Russia

RECRUITING

Aurora MedFort LLC

Saint Petersburg, 194156, Russia

RECRUITING

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

RECRUITING

Limited Liability Company "Stepmed Clinic"

Saint Petersburg, Russia

RECRUITING

Saratov City Psychoneurological Dispensary

Saratov, 410038, Russia

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Neurasthenia; Adjustment Disorders

Interventions

GB-115; 2-((2-morpholino)ethylthio)-5-ethoxybenzimidazole

Condition Hierarchy (Ancestors)

Mental Disorders; Somatoform Disorders; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)