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Compares treatment options for Mood Disorders
Official title Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
ClinicalTrials.gov ID: NCT05656469
What this study is testing
- What it's testing
- A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
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...
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient how well...
- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for...
- 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...
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...
- Liver disease defined as follows: Alanine-Aminotransferase (ALAT) \>70u/L
- Renal disease: Estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2
- Diabetes: Blood glucose \> 11.1 mmol/L or twice a fasting glucose \> 7.0 mmol/L
See the full eligibility criteria
- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI International Neuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic...
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient how well it works of a psychotropic treatment when dosed high enough and...
- 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...
- 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...
- To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study.
- Age between ≥16 and \<70 years.
- Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.
- 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...
- Liver disease defined as follows: Alanine-Aminotransferase (ALAT) \>70u/L
- Renal disease: Estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2
- Diabetes: Blood glucose \> 11.1 mmol/L or twice a fasting glucose \> 7.0 mmol/L
- Cardiac disease: prolonged QT-interval.
- Alcohol and/or substance abuse and/or dependence (except nicotine)
- 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).
- Inability to use the mobile phone application
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Syracuse, New York, United States
- Bonn, Germany
- München, Germany
- Amsterdam, Netherlands
- Maastricht, Netherlands
- Cluj-Napoca, Romania
- Belgrade, Serbia
- Barcelona, Spain
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Syracuse, New York, United States; Bonn, Germany; München, Germany; Amsterdam, Netherlands; Maastricht, Netherlands; Cluj-Napoca, Romania and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.