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Study of prucalopride and escitalopram combination to improve treatment response in patients with major depressive disorder

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What is this trial about?

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

This clinical trial focuses on patients with Major Depressive Disorder. The study investigates whether adding prucalopride, a medication that affects certain receptors in the body, can speed up the effectiveness of escitalopram, which is a type of antidepressant medication known as a selective serotonin reuptake inhibitor (SSRI). Some participants will receive escitalopram with prucalopride, while others will receive escitalopram with placebo.

The study aims to determine if combining these medications leads to better improvement in depression symptoms compared to using escitalopram alone. The treatment period lasts for 6 weeks, during which participants take their assigned medications daily. The medications are given as oral tablets or capsules.

Throughout the study, participants' depression symptoms will be monitored using various assessment tools that measure mood, anxiety, and emotional recognition. The study will also track any side effects that participants may experience, particularly focusing on tiredness, digestive system effects, and headaches.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    You will begin taking two medications: escitalopram (antidepressant) and either prucalopride or a placebo pill

    Both medications are taken orally. The escitalopram comes as a film-coated tablet, while prucalopride/placebo comes as a capsule

    A medical evaluation will be performed, including assessment of depression severity using specific rating scales

  2. Step 2

    Day 3 follow-up

    Your mood and anxiety levels will be evaluated using standardized questionnaires

    Any side effects will be recorded, particularly focusing on fatigue, digestive issues, and headaches

  3. Step 3

    Day 7 assessment

    Comprehensive evaluation of mood and anxiety levels

    Emotional recognition test and emotional memory test will be performed

    Medication adherence will be checked

    Side effects monitoring continues

  4. Step 4

    Day 14 check-up

    Follow-up assessment of mood and anxiety levels

    Continued monitoring of any side effects

  5. Step 5

    Day 28 evaluation

    Assessment of mood and anxiety levels

    Ongoing monitoring of side effects

  6. Step 6

    Final assessment (Day 42)

    Final comprehensive evaluation of mood and anxiety levels

    Emotional recognition and memory tests will be repeated

    Final medication adherence check

    Final side effect assessment

    This marks the end of the 6-week study period

Who can join the trial?

5 criteria

  • Age between 18 and 65 years
  • Diagnosed with major depressive disorder according to DSM-5 criteria (a standardized set of diagnostic criteria for mental health conditions), confirmed through a structured clinical interview with a depression severity score of 19 or higher on the HDRS-21 scale (a tool that measures depression severity)
  • Must be starting treatment with escitalopram (an antidepressant medication) as part of their regular care when entering the study
  • For women who can become pregnant: - Must have a negative pregnancy test at the screening visit - Must use effective contraception throughout the study period
  • Must be enrolled in or eligible for a social security system

Who cannot join the trial?

13 criteria

  • History of hypersensitivity or allergy to escitalopram or prucalopride
  • Presence of other serious psychiatric conditions besides depression (such as schizophrenia, bipolar disorder)
  • Current substance abuse or dependency (alcohol or drugs)
  • Pregnancy or breastfeeding
  • Taking other antidepressant medications in the past 2 weeks
  • Severe heart, liver, or kidney disease
  • History of seizures (sudden, uncontrolled electrical disturbances in the brain)
  • Suicidal thoughts or behavior in the past month
  • Participation in another clinical trial within the past 30 days
  • Unstable medical conditions that could interfere with the study
  • History of gastrointestinal bleeding or other serious digestive system problems
  • Unable to provide informed consent
  • History of not following medical treatment plans
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Investigated drugs

Prucalopride is a medication that works by activating 5-HT4 receptors in the body. It is typically used to treat severe constipation, but in this study, it is being investigated for its potential to enhance the effectiveness of antidepressant treatment. Escitalopram is an antidepressant medication that belongs to a group called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the levels of serotonin in the brain, which helps improve mood, reduce anxiety, and relieve symptoms of depression. The study aims to see if combining these two medications can help people with depression respond better and faster to antidepressant treatment than using escitalopram alone.

What is already known about the treatment

  • Prucalopride

    A prescription medication administered orally that acts as a selective 5-HT4 receptor agonist, primarily used in treating chronic constipation but being investigated for potential antidepressant-enhancing properties. The drug works by stimulating serotonin type-4 receptors in the digestive tract and brain, which may help accelerate the therapeutic effects of selective serotonin reuptake inhibitors (SSRIs) in depression treatment. Currently being studied in Phase II clinical trials, this medication represents a novel approach to improving antidepressant response times.

  • Escitalopram

    An oral antidepressant medication belonging to the selective serotonin reuptake inhibitor (SSRI) class, widely used as a first-line treatment for major depressive disorder. The drug works by increasing serotonin levels in the brain by blocking its reabsorption into nerve cells, which helps improve mood, sleep, appetite, and energy levels. This well-established medication typically takes several weeks to achieve full therapeutic effect and is being studied in combination with prucalopride to potentially accelerate its antidepressant benefits.

Investigated diseases

Major Depressive Disorder - A mood disorder characterized by persistent feelings of sadness, loss of interest in activities, and decreased energy lasting for at least two weeks. The condition affects how a person thinks, feels, and behaves, often leading to emotional and physical problems. People with depression may experience changes in sleep patterns, appetite, concentration, and daily activities. The disorder can develop gradually and may be triggered by life events, though sometimes there is no obvious cause. Depression affects the brain's ability to regulate mood through neurotransmitters, particularly serotonin. The condition can vary in severity and duration, with symptoms fluctuating over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521811-38-01Protocol code38RC24.0407Estimated enrolment70 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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