A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia ā¦ (NCT05586789) | Clinical Trial Compass
CompletedPhase 3
A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders
Russia220 participantsStarted 2022-10-12
Plain-language summary
The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder.
An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Men and women between the ages of 18 and 70
ā. Presence of written consent to participate in the study in accordance with applicable law
ā. Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2)
ā. HARS anxiety scores of 18-24
ā. Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50 points
ā. Hamilton Depression Assessment Scale (HAMD-17) score \< 6
ā. CGI-s scale score of at least 4
ā. Negative pregnancy test for women of preserved reproductive potential
Exclusion criteria
ā. Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
ā. Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
ā. Patients who require concomitant therapy prohibited in this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleeping pills when used on a continuous basis), or have taken these drugs within the last month
ā. Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
What they're measuring
1
Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 Ā± 1
ā. Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
ā. Presence of tuberculosis, including a history of tuberculosis
ā. The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or a positive test for HIV, hepatitis B/C, syphilis at screening
ā. Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)