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Clinical trial to evaluate the effectiveness and efficiency of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT clinical trial.
EU CTIS ID: 2025-522967-13-00
What this study is testing
Evaluate the effectiveness of a personalized medicine strategy that incorporates pre-emptive pharmacogenetic testing of biomarkers associated with antidepressant response, along with demographic, clinical, and concomitant medication data, compared to standard clinical practice in patients with depressive disorder who are initiating a new therapy following prior treatment failure.
- 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
- Ability to understand the study's purpose and risks, provide informed consent, and authorize the use of confidential health information according to national and local privacy regulations.
- Voluntary signing of the informed consent form (ICF).
- Age += 18 years at the time of signing the ICF.
- Ability and willingness to participate and follow the study for the majority of its duration.
- Current first depressive episode, confirmed by a clinical diagnosis of depressive disorder according to standardized diagnostic criteria (e.g., ICD-11 or DSM-5), as documented in the medical record.
- Currently receiving pharmacological treatment for depressive disorder at the time of study inclusion, with no more than one prior antidepressant treatment line, as determined by the treating physician.
You likely can't join if
- Reports suicidal thoughts nearly every day, based on PHQ-9 item 9.
- Participants are unwilling or unable to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Any condition or situation that precludes or interferes with compliance with the protocol.
- The participant is currently enrolled in or has enrolled in a clinical trial within the three months preceding inclusion in the current study.
- History of failure to respond or intolerance to more than one prior antidepressant treatment line for the current depressive episode.
- History of manic, mixed, or hypomanic episodes, which are indicative of a bipolar disorder diagnosis and thus incompatible with inclusion in a depressive disorder trial.
See the full eligibility criteria
- Ability to understand the study's purpose and risks, provide informed consent, and authorize the use of confidential health information according to national and local privacy regulations.
- Voluntary signing of the informed consent form (ICF).
- Age += 18 years at the time of signing the ICF.
- Ability and willingness to participate and follow the study for the majority of its duration.
- Current first depressive episode, confirmed by a clinical diagnosis of depressive disorder according to standardized diagnostic criteria (e.g., ICD-11 or DSM-5), as documented in the medical record.
- Currently receiving pharmacological treatment for depressive disorder at the time of study inclusion, with no more than one prior antidepressant treatment line, as determined by the treating physician.
- Patient Health Questionnaire-9 (PHQ-9) Score: 10, and Montgomery-Asberg Depression Rating Scale (MADRS) Score: 18, both assessed within the two weeks preceding study inclusion.
- No prior genotyping for CYP3A4, SLC6A4, HTR2A, CYP2D6, CYP2B6, or CYP2C19 genes.
- Women of childbearing potential must agree to use highly effective contraception or practice sexual abstinence throughout the study and commit to avoiding pregnancy.
- Reports suicidal thoughts nearly every day, based on PHQ-9 item 9.
- Participants are unwilling or unable to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Any condition or situation that precludes or interferes with compliance with the protocol.
- The participant is currently enrolled in or has enrolled in a clinical trial within the three months preceding inclusion in the current study.
- History of failure to respond or intolerance to more than one prior antidepressant treatment line for the current depressive episode.
- History of manic, mixed, or hypomanic episodes, which are indicative of a bipolar disorder diagnosis and thus incompatible with inclusion in a depressive disorder trial.
- A history of active psychotic episodes is indicative of a potential diagnosis of schizophrenia and is therefore considered incompatible with inclusion in a clinical trial for depressive disorders.
- Depressive-like symptoms attributable to non-depressive conditions, such as Acute Stress Reaction, Uncomplicated Bereavement, or Premenstrual Dysphoric Disorder, which are excluded from the ICD-11 classification of depressive disorders.
- Patients with a documented history of antidepressant treatment prescribed for Adjustment Disorder, Generalized Anxiety Disorder (GAD), or Post-Traumatic Stress Disorder (PTSD).
- Currently hospitalized for psychiatric or medical reasons.
- Have a known active drug substance abuse.
- Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
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, 65+ 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.