Can your genes guide better mental health meds? new trial aims to find out
NCT ID NCT05656469
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a person's genetic information to guide medication choices leads to better recovery for people with mood, anxiety, or psychotic disorders. Over 2,500 participants will receive either standard care or personalized medication advice based on their genetic profile. The goal is to see if this approach improves mental health recovery over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pharmacogenetic testing
- What this could lead to
- If successful, this could make psychiatric medication more personalized, potentially improving recovery rates and reducing trial-and-error prescribing.
- What could go wrong
- This is a large but early-stage trial; genetic testing may not consistently improve outcomes, and results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
RECRUITINGCluj-Napoca, Romania
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Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
RECRUITINGBarcelona, Spain
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King's College, Institute of Psychiatry, Psychology & Neuroscience
RECRUITINGLondon, United Kingdom
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Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
RECRUITINGMünchen, Germany
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Maastricht University, Department of Psychiatry and Neuropsychology
RECRUITINGMaastricht, Netherlands
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Parnassia Psychiatric Institute, Department of Psychiatry
RECRUITINGAmsterdam, Netherlands
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SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
NOT_YET_RECRUITINGSyracuse, New York, 13210, United States
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University Hospital Bonn, Department of Psychiatry and Psychotherapy
RECRUITINGBonn, Germany
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University of Belgrade, Faculty of Pharmacy
RECRUITINGBelgrade, Serbia
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