This study aims to evaluate anxiety and cardiovascular outcomes in individuals with the psycho-cardio phenotype, characterized by clinically relevant anxiety symptoms with or without established cardiovascular disease (CVD). The study will be conducted as a prospective, real-world interventional study over 12 weeks.
Participants will be allocated to either a group receiving Neurofast® supplementation (2 tablets per day) or a control group receiving no additional treatment. Psychological assessments will include the Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Cardiac Anxiety Questionnaire (CAQ). Cardiovascular parameters, including heart rate, blood pressure, and electrocardiographic (ECG) measures, will also be evaluated.
The primary objective is to assess changes in anxiety symptoms and heart rate over 12 weeks. Secondary objectives include evaluation of depressive symptoms, cardiovascular parameters, and treatment adherence in a real-world clinical setting.
Age 18-70 years (both sexes)
GAD-7 ≥ 5 and/or elevated CAQ score
PHQ-9 < 20
Stable clinical status (either no cardiovascular disease or stable cardiovascular disease)
Severe chronic kidney disease (eGFR < 50 ml/min)
Severe hepatic impairment
Psychotic disorders, bipolar disorder, or acute major depression
Unstable psychiatric or pharmacological treatment (<3 months)
Parallel
Neurofast® supplement
Dietary supplementNeurofast® is a nutraceutical formulation administered orally in tablet form and evaluated for its potential effects on psychological and cardiovascular parameters in individuals with the psycho-cardio phenotype.
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Change in anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Change in Cardiac Anxiety Questionnaire (CAQ) score
Change in cardiac-related anxiety measured using the Cardiac Anxiety Questionnaire (CAQ). Higher scores indicate greater cardiac-related anxiety.
Change in heart rate measured by standard 12-lead ECG
Heart rate (beats per minute) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in PR interval measured by standard 12-lead ECG
PR interval (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in Patient Health Questionnaire-9 (PHQ-9) score
Change in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating greater depressive severity.
Change in blood pressure (mmHg)
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) during clinical visits.
Change in standard 12-lead electrocardiographic parameters
Electrocardiographic parameters routinely obtained from a standard 12-lead ECG, including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc), will be assessed and compared between baseline and Week 12.
Treatment adherence
Assessment of adherence to Neurofast supplementation during the study period in a real-world clinical setting.
Click on the lead sponsor to view all of their trials.
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Rome Tor Vergata
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
