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NCT Number: NCT06304233

The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwegian University of Science and Technology, Trondheim, Norway

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About this study

Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
  • Both inpatient and outpatient
  • Capable of giving informed consent

Exclusion criteria

  • Current or previous diagnosis of cancer
  • Current or previous treatment with chemotherapy
  • Current pregnancy
  • Mothers less than 6 months post-partum

Treatment and study plan

Echocardiography

Diagnostic Test

ultrasound assessment of heart structure, volume and function

Other names: Echo

Cardiac magnetic resonance imaging

Diagnostic Test

MRI assessment of heart structure, volume, function and tissue characteristics

Other names: Cardiac MRI, CMRI

Electrocardiography

Diagnostic Test

Assessment of cardiac rhythm and electrical activity

Other names: Holter, ECG

Blood sampling

Other

To measure DISC1 mRNA expression and other potential biomarkers

Primary outcomes

  1. Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography

    Time frame: Baseline

    Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography.

  2. Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography

    Time frame: Baseline

    Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography

  3. DISC1 mRNA quantification

    Time frame: Baseline

    Measured from blood samples and reported as fold change

  4. Levels of high sensitive-CRP

    Time frame: Baseline

    Levels of HS-CRP mg/L

  5. Levels of CK-MB

    Time frame: Baseline

    Levels of CK-MB is reported in µg/L

  6. Levels of Troponin T

    Time frame: Baseline

    Levels of Troponin T is reported in ng/L

  7. Levels of Troponin I

    Time frame: Baseline

    Levels of Troponin I is reported in ng/L

  8. Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter

    Time frame: Baseline

    LV EDV in milliliters (mL) will be normalized against body surface area (BSA) in m^2 to report LV EDV normalized by BSA in mL/m^2.

  9. Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter

    Time frame: Baseline

    RV EDV in mL will be normalized against body surface area (BSA) in m^2 to report RV EDV normalized by BSA in mL/m^2.

  10. Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter

    Time frame: Baseline

    LV ESV in mL will be normalized against body surface area (BSA) in m^2 to report LV ESV normalized by BSA in mL/m^2.

  11. Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter

    Time frame: Baseline

    RV ESV in mL will be normalized against body surface area (BSA) in m^2 to report RV ESV normalized by BSA in mL/m^2.

  12. Left ventricular mass measured by echocardiography

    Time frame: Baseline

    Left ventricular mass in grams (g) will be normalized against BSA in m^2 and reported as g/m ^2

  13. Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography

    Time frame: Baseline

    Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)

  14. Fractional shortening measured by echocardiography

    Time frame: Baseline

    Fractional shortening will be reported as a percentage (%)

  15. Global longitudinal strain (GLS), echocardiographic parameter

    Time frame: Baseline

    GLS(%) = (MLs - MLd)/MLd, where MLs is myocardial length at end-systole and MLd is the myocardial length at end-diastole. GLS will be reported in precentage (%)

  16. TAPSE echocardiographic parameter of right ventricular longitudinal systolic function

    Time frame: baseline

    TAPSE will be reported in millimeters (mm)

  17. Echocardiographic parameter MPI, Myocardial performance index

    Time frame: Baseline

    MPI is a unitless index derived from the sum of the isovolumic relaxation time (IVRT) and the isovolumic contraction time (IVCT) in milliseconds (ms) divided by the ejection time interval in (ms).

  18. Echocardiographic parameter Mitral E/A ratio

    Time frame: Baseline

    Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity

  19. Echocardiography parameter of peak E velocity

    Time frame: Baseline

    peak E velocity is reported in cm/s

  20. Echocardiography parameter of E wave deceleration time

    Time frame: Baseline

    E wave deceleration time is reported in milliseconds (ms)

  21. Echocardiography parameter of ratio of E/e'

    Time frame: Baseline

    The E/e' ratio is derived from the E wave velocity to the e' velocity

  22. Echocardiographic parameters septal e' and lateral e' velocities

    Time frame: Baseline

    Septal e' and lateral e' velocities are reported as cm/s

  23. Echocardiographic parameter LAVI, left atrial volume indexed

    Time frame: Baseline

    LAVI is reported in mL/m^2 and is the volume (mL) of the left atrium indexed against the BSA in m^2.

  24. Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity

    Time frame: Baseline

    TRpV is reported in m/s

  25. Echocardiographic parameter, S wave velocity

    Time frame: Baseline

    S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s

  26. Echocardiographic parameter, Indexed LV and RV stroke volumes

    Time frame: Baseline

    Indexed LV stroke volume and Indexed RV stroke volume will be reported in mL/m^2 by by indexing the volumes (mL) to BSA (m^2)

  27. Levels of NT-proBNP

    Time frame: Baseline

    Levels of NT-proBNP from blood samples will be reported in ng/L

  28. Levels of IGF1

    Time frame: Baseline

    Levels of IGF1 from blood samples will be reported in nmol/L

  29. Levels of ANP

    Time frame: Baseline

    Levels of ANP from blood samples will be reported in pg/mL

  30. Levels of BDNF, brain derived neurotrophic factor

    Time frame: Baseline

    Levels of BDNF from blood samples will be reported in ng/mL

  31. Levels of Tumor Necrosis Factor alpha

    Time frame: Baseline

    Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL

  32. Levels of Transforming Growth Factor Beta

    Time frame: Baseline

    Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL

  33. Levels of cardiac Myosin-Binding Protein C

    Time frame: Baseline

    Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L

  34. Interleukin levels

    Time frame: Baseline

    Interleukin levels from blood sample will be reported as pg/mL

Secondary outcomes

  1. native T1 time, cardiac MRI

    Time frame: Baseline

    native myocardial T1 relaxation time is reported in milliseconds (ms)

  2. Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI

    Time frame: Baseline

    Indexed LV and RV end-diastolic, end-systolic and stroke volumes will be reported in mL/m^2, by indexing the volumes (mL) to BSA (m^2)

  3. Indexed LV mass, cardiac MRI

    Time frame: Baseline

    Indexed LV mass will be reported in g/m^2 by indexing mass (g) to BSA (m^2)

  4. LV Ejection Fraction, cardiac MRI

    Time frame: Baseline

    LVEF will be reported in percent (%)

  5. ECG corrected QT interval

    Time frame: Baseline

    corrected QT interval will be reported in milliseconds (ms)

  6. Number of participants with and abnormal ECG

    Time frame: Baseline

    Number of participants with an abnormal ECG will be reported in %

  7. Number of participants with abnormal liver function

    Time frame: Baseline

    Number of participants with abnormal liver function will be reported as %

  8. Number of participants with abnormal kidney function

    Time frame: Baseline

    Number of participants with abnormal kidney function will be reported as %

  9. Number of participants with abnormal thyroid function

    Time frame: Baseline

    Number of participants with abnormal thyroid function will be reported as %

  10. Number of participants with low Vitamin D levels

    Time frame: Baseline

    Number of participants with low Vitamin D levels will be reported as %

  11. Incidence of cardiovascular disease or mortality as registered in a health registry on follow up

    Time frame: Within 15 years from start of study

    Extraction of information from the cardiovascular disease registry and deaths registry between 10 - 15 years from the start of the study to determine incidence of cardiovascular disease outcomes for the study cohort

  12. Triglyceride levels

    Time frame: Baseline

    Triglyceride will be reported in mmol/L

  13. High-density lipoprotein, HDL-cholesterol levels

    Time frame: Baseline

    HDL-cholesterol levels will be reported in mmol/L

  14. Low-density lipoprotein, LDL-cholesterol levels

    Time frame: Baseline

    LDL-cholesterol levels will be reported in mmol/L

  15. Fasting glucose levels

    Time frame: Baseline

    Fasting glucose levels will be reported in mmol/L

  16. Glycated Hemoglobin (HbA1c) levels

    Time frame: Baseline

    HbA1C will be reported in mmol/mol

  17. Heart rate measured on ECG

    Time frame: Baseline

    Heart rate measured on 12 lead ECG will be reported in beats per minute.

  18. Systolic Blood Pressure

    Time frame: Baseline

    Systolic Blood Pressure will be reported as mmHg

  19. Diastolic Blood Pressure

    Time frame: Baseline

    Diastolic Blood Pressure will be reported as mmHg

  20. Lipoprotein a

    Time frame: Baseline

    Lipoprotein a levels will be reported in mg/L

  21. Magnesium levels

    Time frame: Baseline

    Magnesium levels will be reported as mmol/L

  22. Calcium levels

    Time frame: Baseline

    Calcium levels will be reported as mmol/L

  23. Sodium levels

    Time frame: Baseline

    Sodium levels will be reported as mmol/L

  24. Potassium levels

    Time frame: Baseline

    Potassium levels will be reported as mmol/L

Other outcomes

  1. Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire

    Time frame: Baseline

    The AUDIT-C is a validated 3-item questionnaire for identification of alcohol misuse. Each item has 5 possible responses, each scored from 0 to 4 points. Possible scores range from 0 to 12. The score cut-off for alcohol misuse is 4 points in men and 3 points in women

  2. Average length of inpatient stay for schizophrenia related admissions

    Time frame: Baseline

    The average length of inpatient stays will be reported as number of days and derived from the total number of days spent admitted over the total number of admissions.

  3. Need of Care based on number of total hospital admission for schizophrenia

    Time frame: Baseline

    Number of hospital admissions

  4. Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity

    Time frame: Baseline

    CGI for severity is a validated scale used to assess psychiatric illness severity by a clinician. Possible scores range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients)

  5. Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS)

    Time frame: Baseline

    PANSS/SCI-PANSS are validated clinician administered scale used to measure symptom severity in schizophrenia and consists of 30 items divided into 3 subscales: Positive Scale, Negative Scale and the General Pathology Scale. Each subscale can be scored from 1 (absent) to 7 (extreme). Possible scores for the Positive and Negative scales range from 7 - 49, and for the General Psychopathology Scale range from 16 - 112. The further developed SCI-PANSS (structured clinical interview - for the Positive and Negative Syndrome Scale).

  6. Duration of schizophrenia

    Time frame: Baseline

    Duration of schizophrenia as determined from self reported year of first episode of diagnosis/ or from date of diagnosis

  7. Length of treatment with an antipsychotic medication

    Time frame: Baseline

    The length of treatment with an antipsychotic medication will be reported in years

  8. Antipsychotic dosage in daily equivalent dosage of chlorpromazine

    Time frame: Baseline

    Antipsychotic dosages will also be converted to daily equivalent dosage of chlorpromazine for comparison across different medication will be reported in mg/day

  9. Smoking status

    Time frame: Baseline

    Number of participants who smoke will be reported in percent (%)

  10. Waist Hip Ratio

    Time frame: Baseline

    Waist Hip measurements will be reported as a ratio

  11. Body Mass Index

    Time frame: Baseline

    Body Mass Index, BMI will be derived from participants weight and height and reported as kg/m^2

  12. Body fat percent

    Time frame: Baseline

    Body fat percent from body composition analysis will be reported in %

  13. Physical Activity

    Time frame: Baseline

    Baseline physical activity measured using the International Physical Activity Questionnaire (IPAQ) The IPAQ is validated in schizophrenia populations and the IPAQ has been validated in Norwegian populations. It is a self reported scoring system assessing physical activity over the last seven days. Physical activity can be then represented in minutes/week or MET-minutes/week.

  14. Body muscle composition

    Time frame: Baseline

    Body muscle mass will be reported in kg

  15. Smoking history

    Time frame: Baseline

    Smoking will be quantified and reported as pack/years

  16. Age of participant

    Time frame: Baseline

    Age of participant will be reported in years

  17. Gender of participant

    Time frame: Baseline

    Gender of participant will be reported as male or female

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - The Link Between DISC1 and Cardiac Function in Patients With Schizophrenia

Important dates

Study start
2023
Primary completion
2026
Study completion
2038
First posted
Mar 12, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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