VLT-015 in Patients With Schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- NCT05516121
- Lead Sponsor
- CF Pharma, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria:<br><br> - Male patients aged 18 to 50<br><br> - Availability of a voluntarily signed Information Consent (Patient Information Sheet)<br> for participation in this clinical research and further hospitalization;<br><br> - The diagnosis of schizophrenia established in the anamnesis<br><br> - The patient's stay in remission** based on the decision of the investigator before<br> and after the withdrawal of maintenance therapy.<br><br>Criteria determining the state of remission:<br><br> - the sum of points of the Positive and Negative Symptom Scale (PANSS) according to<br> positive Marder factor is less than 22 points,<br><br> - each item score of the positive Marder factor (delusions, hallucinatory behavior,<br> grandiosity, suspicion, stereotyped thinking, somatic anxiety, unusual thought<br> content, decreased criticism) less than 4 points<br><br> - Absence of taking antipsychotic drugs for 5 periods half-life of the drug<br> taken;<br><br> - The patient's ability to adequately cooperate (the ability to understand<br> provided information about the clinical trial, readiness for compliance with<br> the requirements of the study protocol);<br><br> - Agree to use barrier methods of contraception during the study and within 2<br> months after completion of the study.<br><br>Exclusion Criteria:<br><br> 1. The presence of contraindications to the use of VLT-015:<br><br> - dysfunction of the bone marrow;<br><br> - hypersensitivity to VLT-015 and other components of the drug;<br><br> - toxic or idiosyncratic granulocytopenia/agranulocytosis in history;<br><br> - epilepsy;<br><br> - alcohol, drug intoxication and coma;<br><br> - collapse, depression of the central nervous system of any etiology;<br><br> - severe kidney or heart disease;<br><br> - paralytic intestinal obstruction;<br><br> - glucose-galactose malabsorption;<br><br> - renal or hepatic insufficiency;<br><br> 2. Patients requiring medication or other concomitant therapies listed in the<br> unacceptable concomitant therapy section;<br><br> 3. The presence of prostatic hyperplasia or glaucoma in patients;<br><br> 4. Diseases of the bone marrow in history;<br><br> 5. Active tuberculosis, cystic fibrosis, systemic connective tissue diseases,<br> oncological processes of any localization;<br><br> 6. Severe, decompensated or unstable somatic diseases (any diseases or conditions that<br> threaten the patient's life or worsen the prognosis patient, and also make it<br> impossible to conduct a clinical trial);<br><br> 7. Alcoholism and drug addiction at the present time, or in history;<br><br> 8. Lack of patient willingness to cooperate, non-compliance of the patient;<br><br> 9. Participation of the patient in any other clinical study in the last 30 days;<br><br> 10. Patients planning to stay in the hospital during the study period for reasons other<br> than the purposes of this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;Tmax;AUC o-t;AUC o - 8;AUC o-t/AUC o-8;T1/2;MRT
- Secondary Outcome Measures
Name Time Method