Actively Recruiting
Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Led by Valenta Pharm JSC · Updated on 2025-07-08
250
Participants Needed
6
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 70 years
- Written informed consent as per current legislation
- Diagnosed with anxiety due to neurasthenia (F48.0) or adjustment disorder (F43.2) based on ICD-10
- Anxiety severity on Hamilton Anxiety Rating Scale between 18 and 24 points
- Suicidal thoughts severity less than 3 points on Columbia scale
- Asthenia severity greater than 50 points on Multidimensional Fatigue Inventory Scale (MFI-20)
- Total score less than 6 on Hamilton Depression Rating Scale (HAMD-17)
- Score of at least 4 points on CGI-s scale
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception throughout the study and for 30 days after completion (women of childbearing potential and men)
- Ability to understand study requirements, provide informed consent, and comply with study protocol
You will not qualify if you...
- Known intolerance to active or inactive substances in study drugs
- Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance
- Use of prohibited therapies (MAO inhibitors, antidepressants, neuroleptics, anxiolytics, sedatives, hypnotics) currently or within last month
- Alcohol, narcotic, or drug dependence or use at screening/randomization
- Presence or history of oncological diseases except cured tumors in stable remission for over 5 years
- History or presence of tuberculosis
- Presence or history of HIV, chronic viral hepatitis B/C, or syphilis
- Diagnosis of other anxiety disorders (F41) or schizophrenia, schizoaffective, affective, panic disorders
- Acute psychosis, organic CNS lesions, post-encephalitic syndrome, brain tumors, degenerative CNS diseases
- History of depression or suicide attempts
- Generalized anxiety disorder history
- History of epilepsy or seizures
- Decompensated diabetes mellitus
- Chronic kidney disease stage 3A or higher, or eGFR ≤ 59 ml/min/1.73 m²
- Liver failure or elevated liver enzymes >3 times normal
- Major surgery within 6 months prior to screening
- Chronic heart failure class III-IV (NYHA)
- Severe, unstable, or life-threatening diseases
- Pregnant, breastfeeding, or planning pregnancy during study or 30 days after
- Refusal to use contraception or abstain from sexual contact during study and 30 days after
- Current or planned psychological/psychotherapeutic treatment for anxiety during trial
- Participation in other clinical trials within 90 days prior to screening
- Lack of cooperation or other investigator-determined reasons hindering participation
- Withdrawal of consent or decision to discontinue
- Serious adverse events or safety concerns during study
- Significant treatment regimen violations
- Positive pregnancy test during study
- Confirmed COVID-19 diagnosis
- Death or study termination by sponsor, investigator, or authorities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region
Engel's, Russia, 413090
Actively Recruiting
2
Unimed-C Jsc
Moscow, Russia, 119571
Actively Recruiting
3
Aurora MedFort LLC
Saint Petersburg, Russia, 194156
Actively Recruiting
4
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, Russia, 196143
Actively Recruiting
5
Limited Liability Company "Stepmed Clinic"
Saint Petersburg, Russia
Actively Recruiting
6
Saratov City Psychoneurological Dispensary
Saratov, Russia, 410038
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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