Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorValenta Pharm JSC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Ranquilon
Drug1 mg tablets
Afobazole
Drug10 mg tablets
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Ranquilon, 6 mg/dayExperimental treatment 1 intervention
Group B: Afobazole, 30 mg/dayActive comparator 1 intervention
Trial outcomes
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.
Time frame
Day 29 ± 1 (Visit 3)Secondary outcomes
1
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)2
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)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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov