RecruitingNot applicable

Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

A New Intervention for Implementation of Pharmacogenetics in Psychiatry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 24-week study compares medicine treatment guided by gene tests with usual dosing. It is for people ages 16 to 69 with depression, anxiety, or a disorder such as schizophrenia whose past mental health medicine did not work well or caused side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 16 to 69 years old.
  • Have at least moderate symptoms of depression (including bipolar depression), panic disorder, generalized anxiety disorder, schizophrenia, or schizoaffective disorder. Study interviews and rating scales will check this.
  • Have tried at least one mental health medicine that did not work well enough despite a high enough dose and enough time, or was stopped because of side effects.
  • Be about to switch medicines, or have switched within 2 weeks before first contact with the study team, because the last medicine did not work well or caused side effects. The new medicine must be sertraline or escitalopram for depression or anxiety, or aripiprazole or risperidone for schizophrenia or schizoaffective disorder.
  • Currently get mental health treatment in a hospital or through clinic visits.
  • Understand the study and sign a form agreeing to take part.
  • Give written permission to use and share information from your medical records for the study.
  • Own an Android phone or iPhone for automatic tracking.

Who can't join

  • Have already had gene testing to guide medicine treatment.
  • Have never taken mental health medicine.
  • Have serious physical health problems that meet the study's test limits: liver disease, kidney disease, diabetes, or a heart rhythm problem called a long QT interval.
  • Have alcohol or drug abuse or dependence, except for nicotine.
  • Regularly use 5 or more medicines, including prescription, store-bought, traditional, or complementary medicines.
  • Cannot use the study's phone app.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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 and Statistical Manual (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 (panic disorder, generalised anxiety disorder) (as assessed by the M.I.N.I. 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 M.I.N.I. 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). 2. 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. 3. 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. 4. Currently receiving inpatient or outpatient psychiatric treatment. 5. 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 participation in the study. 6. To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study. 7. Age between ≥16 and \<70 years. 8. Ownership of a mobile phone (Android or iOS operation system) for passive monitoring. Exclusion Criteria: 1. Patients with a history of prior pharmacogenomic testing 2. Patients with no prior use of psychotropic medication (medication-naïve patients) 3. 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: 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. 4. Alcohol and/or substance abuse and/or dependence (except nicotine) 5. 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). 6. Inability to use the mobile phone application 7. Pregnant or breastfeeding women

Study sites (1)

NY

  • SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences · Syracuse, NY 13210Thomas Schulze, Prof. Dr. · Study contactThomas Schulze, Prof. Dr. · Principal investigatorMore trials in Syracuse