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Study on Personalized Dosing of Sertraline, Aripiprazole, and Risperidone for Patients with Mood, Anxiety, or Psychotic Disorders

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications on individuals with various mental health conditions. The diseases being studied include major depressive disorder, bipolar disorder (currently in a depressive episode), anxiety disorders such as panic disorder and generalized anxiety disorder, and psychotic disorders like schizophrenia and schizoaffective disorder. The medications involved in this study are sertraline, escitalopram, aripiprazole, and risperidone. These medications are commonly used to treat mood, anxiety, and psychotic disorders.

The purpose of the study is to compare how well patients respond to medication doses that are personalized based on their genetic makeup, known as pharmacogenetics, versus the usual dosing methods. Participants will be randomly assigned to receive either the personalized dosing or the usual dosing, which may include a placebo. The study will last for 24 weeks, during which participants will take the medication orally in the form of tablets. Throughout the study, participants' recovery, well-being, and quality of life will be monitored, along with any side effects they may experience.

Pharmacogenetics is a field of medicine that looks at how a person's genes can affect their response to drugs. By understanding these genetic differences, doctors can tailor treatments to each individual, potentially improving the effectiveness of the medication and reducing side effects. This study aims to see if using pharmacogenetics can lead to better outcomes for patients with these mental health conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written consent to participate and allow the use of clinical data from their medical records.

    Eligibility is confirmed based on specific criteria, including age, current psychiatric treatment, and a history of inadequate response to previous treatments.

  2. Step 2

    Medication administration

    Patients with mood or anxiety disorders will switch to sertraline or escitalopram, while those with psychotic disorders will switch to aripiprazole or risperidone.

    All medications are administered orally. The dosage and frequency are individualized based on pharmacogenetic testing.

  3. Step 3

    Treatment period

    The treatment period lasts for 24 weeks. During this time, the patient's recovery is assessed using the patient recovery assessment scale.

    Additional assessments include well-being, quality of life, psychosocial functioning, clinical symptoms, and side effects.

  4. Step 4

    End of study assessment

    At the end of the 24-week period, a final assessment is conducted to evaluate the patient's recovery and overall response to the treatment.

    The study aims to compare individualized medication dosing based on pharmacogenetics with standard dosing practices.

Who can join the trial?

8 criteria

  • Have a **depressive episode** (a period of feeling very sad or down) or an **anxiety disorder** (such as panic attacks or extreme fear of social situations) or a **psychotic disorder** (like schizophrenia, which affects how you think and feel) that is at least moderately severe.
  • Have not responded well to at least one **psychotropic treatment** (medication for mental health) in the past. This means the medication did not work well enough or had to be stopped because of side effects.
  • Are about to change, or have recently changed, to specific medications: sertraline or escitalopram for mood or anxiety disorders, or aripiprazole or risperidone for psychotic disorders, because the current or previous medication did not work well or caused problems.
  • Are currently receiving psychiatric treatment, either as an inpatient (staying in a hospital) or outpatient (visiting a clinic or hospital).
  • Understand what the study involves and agree to participate by signing a consent form.
  • Agree to allow the use of their medical information for the study.
  • Are between 18 and 64 years old.
  • If a woman can become pregnant, she must have a negative pregnancy test before joining the study and agree to use effective birth control methods during the study.

Who cannot join the trial?

3 criteria

  • Patients with a mood disorder, such as major depressive disorder or bipolar disorder, cannot participate. A mood disorder affects a person's emotional state.
  • Patients with an anxiety disorder, like panic disorder, social phobia, specific phobia, agoraphobia, or generalized anxiety disorder, are excluded. Anxiety disorders involve excessive fear or worry.
  • Patients with a psychotic disorder, such as schizophrenia or schizoaffective disorder, are not eligible. Psychotic disorders can cause distorted thinking and perceptions.
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Investigated drugs

  • Pharmacogenetics-Based Medication

    This medication approach involves adjusting the dose of psychiatric medications based on a patient's genetic makeup. The goal is to tailor the treatment to the individual's genetic profile to improve effectiveness and reduce side effects. This personalized method aims to find the most suitable medication and dosage for each patient, potentially leading to better treatment outcomes in psychiatric care.

  • Standard Psychiatric Medication

    This refers to the usual practice of prescribing psychiatric medications without considering the patient's genetic information. The dosing is based on general guidelines and clinical experience. This approach is commonly used in psychiatric treatment and serves as a comparison to the pharmacogenetics-based method in the trial.

What is already known about the treatment

Sertraline – Sertraline is an oral medication commonly used to treat mood disorders such as major depressive disorder and anxiety disorders like panic disorder and social phobia. It is currently well-established in medical practice and literature as an effective treatment for these conditions. The drug works by increasing the levels of serotonin, a neurotransmitter, in the brain, which helps improve mood and reduce anxiety. Sertraline belongs to a class of medications known as selective serotonin reuptake inhibitors (SSRIs).

Investigated diseases

  • Major Depressive Disorder

    This is a mood disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can lead to a variety of emotional and physical problems, affecting a person's ability to function in daily life. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can occur in episodes, with periods of remission in between. It is often triggered by a combination of genetic, biological, environmental, and psychological factors.

  • Bipolar Disorder (Depressive Episode)

    This is a mood disorder that involves episodes of depression similar to those in major depressive disorder. During a depressive episode, individuals may experience intense sadness, loss of energy, and disinterest in activities they once enjoyed. These episodes can alternate with periods of mania or hypomania, where the person feels overly energetic or irritable. The depressive episodes can vary in duration and intensity. The disorder is influenced by genetic and environmental factors.

  • Panic Disorder

    This anxiety disorder is characterized by recurrent and unexpected panic attacks, which are sudden periods of intense fear or discomfort. These attacks can include symptoms such as heart palpitations, sweating, trembling, and feelings of impending doom. Individuals with panic disorder often worry about having more attacks and may avoid situations where they previously occurred. The disorder can significantly impact daily life and functioning. It often develops in late adolescence or early adulthood.

  • Social Phobia

    Also known as social anxiety disorder, this condition involves an intense fear of social situations where one might be judged or scrutinized by others. Individuals with social phobia may avoid public speaking, meeting new people, or eating in public due to fear of embarrassment. This fear can interfere with daily activities and relationships. The disorder often begins in childhood or adolescence. It is influenced by genetic, environmental, and psychological factors.

  • Specific Phobia

    This anxiety disorder is characterized by an intense and irrational fear of a specific object or situation, such as heights, animals, or flying. The fear is disproportionate to the actual danger posed and can lead to avoidance behavior. Encountering the feared object or situation can trigger immediate anxiety or panic. The disorder can develop at any age and is often linked to a traumatic event or learned behavior. It can significantly impact a person's daily life and activities.

  • Agoraphobia

    This anxiety disorder involves a fear of being in situations where escape might be difficult or help unavailable if panic-like symptoms occur. People with agoraphobia often avoid places like crowded areas, public transportation, or open spaces. The fear can lead to significant avoidance behavior, restricting the person's ability to function outside their home. It often develops in conjunction with panic disorder. The disorder can be influenced by genetic, psychological, and environmental factors.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509680-25-00Protocol codeNL79649.068.21Estimated enrolment1 470 patientsSponsorParnassia Groep B.V.

sourced from the EU Clinical Trials Register and site verification

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