Not Yet RecruitingNot Applicable

Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype Adults

Italy80 participantsStarted 2026-04-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * Ability to provide informed consent Exclusion Criteria: * 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) * Pregnancy or breastfeeding * Known allergy or intolerance to investigational treatments (if applicable)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Generalized Anxiety Disorder-7 (GAD-7) score

Timeframe: Baseline to Week 12

Change in Cardiac Anxiety Questionnaire (CAQ) score

Timeframe: Baseline to Week 12

Change in heart rate measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in PR interval measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in QRS duration measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in corrected QT interval (QTc) measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07502807

SponsorLiaquat University of Medical & Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Anxiety trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Generalized Anxiety Disorder-7 (GAD-7) score

Timeframe: Baseline to Week 12

Change in Cardiac Anxiety Questionnaire (CAQ) score

Timeframe: Baseline to Week 12

Change in heart rate measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in PR interval measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in QRS duration measured by standard 12-lead ECG

Timeframe: Baseline to Week 12

Change in corrected QT interval (QTc) measured by standard 12-lead ECG

Timeframe: Baseline to Week 12