AnxietyNCT07502807
Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype Adults
A study testing Neurofast® supplement in people with Anxiety and Cardiovascular Diseases, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety, Cardiovascular Diseases
- What is being tested?
- Neurofast® supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Rome Tor Vergata
Roma, 00133
Dr. Barbara Pala, MD, barbara.pala93@gmail.com
About this study
Official title: Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype: A Prospective Real-World Interventional Observational Study
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.
Read the detailed description
Mental health and cardiovascular disease are closely interconnected, with anxiety symptoms influencing cardiovascular outcomes, quality of life, and adherence to treatment. This study focuses on individuals presenting with the psycho-cardio phenotype, defined as the coexistence of clinically relevant anxiety symptoms with or without established cardiovascular disease.
This is a prospective, real-world interventional study conducted in a clinical practice setting. Participants will be followed for 12 weeks with repeated psychological and cardiovascular assessments. Eligible participants will include adults aged 18-70 years with GAD-7 ≥ 5 and/or elevated CAQ scores and stable clinical status.
Participants will be allocated into two groups: one group receiving Neurofast® supplementation (2 tablets daily, one in the morning and one in the evening) and one control group receiving no additional treatment. Assessments will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks.
Psychological assessments will include GAD-7 for anxiety, PHQ-9 for depressive symptoms, and CAQ for cardiac-related anxiety. Cardiovascular assessments will include electrocardiography (ECG), heart rate, and blood pressure measurements. Laboratory evaluations, including glucose, lipid profile, and kidney function, will also be performed.
The primary outcome is the change in anxiety scores (GAD-7 and CAQ) and heart rate at 12 weeks. Secondary outcomes include changes in depressive symptoms (PHQ-9), cardiovascular parameters, and assessment of treatment adherence and tolerability in a real-world clinical context.
The study will be conducted in accordance with the Declaration of Helsinki and has received ethics approval from the Calabria Region Ethics Committee (Ref. No. 97/20.04.2023). All participants will provide written informed consent prior to enrollment.
- Conditions
- Anxiety, Cardiovascular Diseases
- Being tested
- Neurofast® supplement
- Medical subject headings
- Anxiety Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofast® supplementDietary supplement
Also called Neurofast®
Neurofast® 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.
| Study group | Role | What they receive |
|---|---|---|
| Neurofast® Supplementation | Experimental | Participants in this group will receive Neurofast® supplementation at a dose of 2 tablets per day (one tablet in the morning and one tablet in the evening) for a duration of 12 weeks, in addition to standard clinical care in a real-world setting. Receives: Dietary Supplement: Neurofast® supplement |
| No Additional Treatment Control | No intervention | Participants in this group will not receive Neurofast® supplementation and will continue with standard clinical care without any additional intervention during the 12-week follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
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.
Measured: Baseline to Week 12
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.
Measured: Baseline to 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.
Measured: Baseline to Week 12
Change in QRS duration measured by standard 12-lead ECG
QRS duration (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Measured: Baseline to Week 12
Change in corrected QT interval (QTc) measured by standard 12-lead ECG
Corrected QT interval (QTc, milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Measured: Baseline to Week 12
Secondary outcomes (4)
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.
Measured: Baseline to Week 12
Change in blood pressure (mmHg)
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) during clinical visits.
Measured: Baseline to Week 12
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.
Measured: Baseline to Week 12
Treatment adherence
Assessment of adherence to Neurofast supplementation during the study period in a real-world clinical setting.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start7 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to one of two parallel groups: a group receiving Neurofast® supplementation (2 tablets per day) and a control group receiving no additional treatment, with follow-up over 12 weeks in a real-world clinical setting.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502807
- Sponsor's protocol ID
- Ref. No. 97/20.04.2023
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype: A Prospective Real-World Interventional Observational Study
- ClinicalTrials.gov ID
- NCT07502807
- Acronym / sponsor ID
- Ref. No. 97/20.04.2023
- Conditions
- Anxiety, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mental health and cardiovascular disease are closely interconnected, with anxiety symptoms influencing cardiovascular outcomes, quality of life, and adherence to treatment. This study focuses on individuals presenting with the psycho-cardio phenotype, defined as the coexistence of clinically relevant anxiety symptoms with or without established cardiovascular disease.
This is a prospective, real-world interventional study conducted in a clinical practice setting. Participants will be followed for 12 weeks with repeated psychological and cardiovascular assessments. Eligible participants will include adults aged 18-70 years with GAD-7 ≥ 5 and/or elevated CAQ scores and stable clinical status.
Participants will be allocated into two groups: one group receiving Neurofast® supplementation (2 tablets daily, one in the morning and one in the evening) and one control group receiving no additional treatment. Assessments will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks.
Psychological assessments will include GAD-7 for anxiety, PHQ-9 for depressive symptoms, and CAQ for cardiac-related anxiety. Cardiovascular assessments will include electrocardiography (ECG), heart rate, and blood pressure measurements. Laboratory evaluations, including glucose, lipid profile, and kidney function, will also be performed.
The primary outcome is the change in anxiety scores (GAD-7 and CAQ) and heart rate at 12 weeks. Secondary outcomes include changes in depressive symptoms (PHQ-9), cardiovascular parameters, and assessment of treatment adherence and tolerability in a real-world clinical context.
The study will be conducted in accordance with the Declaration of Helsinki and has received ethics approval from the Calabria Region Ethics Committee (Ref. No. 97/20.04.2023). All participants will provide written informed consent prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated to one of two parallel groups: a group receiving Neurofast® supplementation (2 tablets per day) and a control group receiving no additional treatment, with follow-up over 12 weeks in a real-world clinical setting.
| Arm | Type | Receives |
|---|---|---|
| Neurofast® Supplementation | Experimental | Dietary Supplement: Neurofast® supplementParticipants in this group will receive Neurofast® supplementation at a dose of 2 tablets per day (one tablet in the morning and one tablet in the evening) for a duration of 12 weeks, in addition to standard clinical care in a real-world setting. |
| No Additional Treatment Control | No intervention | –Participants in this group will not receive Neurofast® supplementation and will continue with standard clinical care without any additional intervention during the 12-week follow-up period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofast® supplementAlso: Neurofast®Neurofast® 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. | Dietary supplement | Neurofast® Supplementation |
Primary outcome
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
PR interval (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in QRS duration measured by standard 12-lead ECG
Time frame: Baseline to Week 12
QRS duration (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in corrected QT interval (QTc) measured by standard 12-lead ECG
Time frame: Baseline to Week 12
Corrected QT interval (QTc, milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
4 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline to Week 12
Change in blood pressure (mmHg)
Time frame: Baseline to Week 12
Change in standard 12-lead electrocardiographic parameters
Time frame: Baseline to Week 12
Treatment adherence
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofast® supplement in people with Anxiety and Cardiovascular Diseases, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder-7 (GAD-7) score (time frame: Baseline to Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.