BridgeMD
A New Intervention for Implementation of Pharmacogenetics in Psychiatry
EU CTIS ID: 2023-509680-25-00
What this study is testing
Compare individualised medication dosing based on pharmacogenetics in psychiatric patients with dosing as usual
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (for example panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher)
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability
- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication.
- Currently receiving inpatient or outpatient psychiatric treatment
- Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before any procedure of the study.
- To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study
You likely can't join if
- Patients with a history of prior pharmacogenomic testing
- Patients with no prior use of psychotropic medication (medication-naïve patients)
- Severe somatic comorbidities as reported in the subject’s medical history or based on clinical chemistry/electrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and/or clinical chemistry and/or ECG at the screening visit, participation is not possible: Liver disease defined as follows: Alanine-Aminotransferase (ALAT) >70u/L; Renal disease defined as: Estimated glomerular filtratrion rate (eGFR) < 60mL/min/1.73m2; Uncontrolled diabetes considering screening blood tests (Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L); Cardiac disease defined as: prolonged QT-interval
- Alcohol and/or substance abuse and/or dependence (except nicotine) , allowing mild substance/ alcohol use disorder (as assessed by the MINI in agreement with DSM-5 criteria).
- Polypharmacy defined as the routine use of five or more medications including over-the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019) , excluding the study medication.
- Pregnant or breastfeeding women
See the full eligibility criteria
Who can join
- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (for example panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher)
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability
- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication.
- Currently receiving inpatient or outpatient psychiatric treatment
- Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before any procedure of the study.
- To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study
- Age between ≥18and <65 years
- Women of child-bearing potential must have a negative pregnancy test in serum/urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion,vasectomized partner and sexual abstinence. Hormonal contraceptive methods is accepted because there are no additional risk for this trial.
What rules you out
- Patients with a history of prior pharmacogenomic testing
- Patients with no prior use of psychotropic medication (medication-naïve patients)
- Severe somatic comorbidities as reported in the subject’s medical history or based on clinical chemistry/electrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and/or clinical chemistry and/or ECG at the screening visit, participation is not possible: Liver disease defined as follows: Alanine-Aminotransferase (ALAT) >70u/L; Renal disease defined as: Estimated glomerular filtratrion rate (eGFR) < 60mL/min/1.73m2; Uncontrolled diabetes considering screening blood tests (Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L); Cardiac disease defined as: prolonged QT-interval
- Alcohol and/or substance abuse and/or dependence (except nicotine) , allowing mild substance/ alcohol use disorder (as assessed by the MINI in agreement with DSM-5 criteria).
- Polypharmacy defined as the routine use of five or more medications including over-the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019) , excluding the study medication.
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.