A Double-blind, Randomized, Placebo-controlled, Multicenter Phase III Clinical Trial to Examine the Clinical Efficacy and Safety of Ranquilon, 1 mg Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    220
  • sponsor
    Valenta Pharm JSC
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Updated on 23 October 2022
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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.

Details
Condition Anxiety, Neurasthenia, Adjustment Disorders
Treatment Placebo, Ranquilon
Clinical Study IdentifierNCT05586789
SponsorValenta Pharm JSC
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and women between the ages of 18 and 70
Presence of written consent to participate in the study in accordance with applicable law
Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2)
HARS anxiety scores of 18-24
Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50 points
Hamilton Depression Assessment Scale (HAMD-17) score < 6
CGI-s scale score of at least 4
Negative pregnancy test for women of preserved reproductive potential
Consent to use effective contraception for the duration of the study and 30 days after completion (for women of unresolved reproductive potential and men)
Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol

Exclusion Criteria

Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
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
Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
Presence of tuberculosis, including a history of tuberculosis
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
Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)
Schizophrenia, schizoaffective, affective and panic disorders
Acute psychosis (endogenous-procedural, organic or somatogenic), including history
Organic lesions of the central nervous system of traumatic and alcoholic genesis
Postencephalitic syndrome
Brain tumors, including in the anamnesis
Degenerative diseases of the central nervous system (CNS), in particular, multiple sclerosis
Depression, including a history of depression
Generalized anxiety disorder, including a history
Suicidal thoughts or ideas; a history of suicide attempts
Epilepsy, seizures, including a history of seizures
Diabetes mellitus at the stage of decompensation
Established diagnosis of chronic kidney disease stage 3A or higher, or glomerular filtration rate (GFR) calculated by the Cockcroft-Gault formula = 59 ml/min/1.73 m2 or less
Established diagnosis of hepatic failure of any severity, or elevated ALT, AST or total bilirubin, urea >3 times the upper limit of normal values
Conditions after major surgical interventions, if less than six months have elapsed since the intervention
Chronic heart failure New York Heart Association (NYHA) functional class III-IV
Severe, decompensated, or unstable disease (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible to perform a clinical trial in the patient)
Pregnant women, women breastfeeding, or women planning to become pregnant during the study and 30 days after study participation ends
Refusal by the patient to use approved contraception or to completely abstain from sexual intercourse during the entire period of study participation, beginning at Visit 0, and for 30 days after completion of study participation
Patient's current or planned participation in psychological or psychotherapeutic interventions designed to treat an anxiety disorder during the course of the clinical trial
Participation in any other clinical trial within 90 days prior to the screening period
Lack of willingness to cooperate on the part of the patient
Other reasons that, in the opinion of the investigator, prevent the patient from participating in the study or pose an unreasonable risk to the patient
Withdrawal Criteria
Patient's desire to stop participating in the study (withdrawal of informed consent) Each patient has the right to stop participating in the study at any time without giving a reason. Withdrawal from the study will not affect the medical care provided to the patient in the future
A decision by the research physician that the patient should be excluded is in the patient's own best interest
Patient refuses to cooperate with the investigator or is undisciplined
Causes/occurrence of situations during the study that threaten patient safety (e.g., hypersensitivity reactions, SAE, etc.)
Inclusion of a patient in the study with inclusion/inclusion criteria not met (prior to randomization)
Significant violation of the treatment regimen A significant violation is defined as
skipping study drug/placebo for 2 consecutive full days or more, or b) taking, in total, < 80% or >120% of the full course (full course = 168 pills)
Positive pregnancy test
Confirmed diagnosis of COVID-19
Occurrence in the course of the study of other reasons that prevent the study according to the protocol
Death of a patient
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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