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Efficacy of fluoxetine added to standard anti‑seizure therapy in children aged 8 years and older with drug‑resistant complex and rare epilepsy

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What is this trial about?

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

The trial focuses on children aged eight years and older who have drug‑resistant, complex and rare epilepsy, a condition where seizures continue despite standard medicines. The investigational drug being evaluated is fluoxetine, an oral medication taken at a dose of 40 mg each day, and it is tested as an addition to the usual anti‑seizure treatment compared with a matching placebo added to the same standard therapy. The purpose of the study is to determine whether the addition of fluoxetine can lower the number of seizures experienced by these children.

Participants first go through a short titration phase, during which the study medication dose is slowly increased to the target amount to help the body adjust. After reaching the target dose, a maintenance period of up to sixteen weeks follows, during which the dose remains steady and seizure activity is recorded. The study is randomized, double‑blind, and placebo‑controlled, meaning that assignment to fluoxetine or placebo is random and neither the participants nor the investigators know which one is being taken.

In addition to counting seizures, the study monitors side effects, measures fluoxetine levels in the blood, and evaluates changes in behavior using a standardized child behavior checklist, which is a questionnaire completed by caregivers to assess mood and conduct. Any increase in seizure severity or appearance of new seizure types is also documented, and all observations are used to assess the overall safety and effectiveness of the treatment.

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

    Baseline assessment

    After joining the study, a detailed record of the number of seizures that occurred before treatment begins is made. this record will be used to set the individual target number of seizures for later comparison.

    A child behavior checklist is completed to evaluate behavior at the start of the study.

    Any current anti‑seizure medicines (treatment as usual) are noted, and a blood sample may be taken for routine safety tests.

  2. Step 2

    Randomization

    The study team assigns the participant to receive either fluoxetine or a matching placebo without the participant knowing which one is given. the assignment is done by a computer program to keep it unbiased.

  3. Step 3

    Study drug titration

    The assigned study drug is taken by mouth once each day. the dose is gradually increased until the target dose of fluoxetine 40 mg per day (or the equivalent amount of placebo) is reached.

    The titration period lasts until the target dose is achieved; the exact number of days is decided by the study physician based on safety and tolerability.

    During titration, the participant continues to take all usual anti‑seizure medicines and records any seizures that occur each day.

  4. Step 4

    Maintenance phase

    Once the target dose is reached, the participant continues to take the study drug daily for up to sixteen weeks.

    The daily dose remains fluoxetine 40 mg (or placebo) throughout this period.

    The participant keeps a daily diary of every seizure and any side effects.

    Regular visits are scheduled to review the seizure diary, assess behavior with the child behavior checklist, and check for adverse events.

  5. Step 5

    Monitoring visits and blood sampling

    A visit is held at the end of the titration period to confirm the target dose and to take a blood sample for measuring fluoxetine levels (for participants receiving the active drug).

    Additional visits occur during the maintenance phase, including a mid‑point visit (about eight weeks) and a final visit at the end of sixteen weeks.

    At each visit, the study team reviews seizure counts, behavior scores, and any adverse events, and may draw another blood sample to check drug levels.

  6. Step 6

    Final assessment and study end

    At the conclusion of the sixteen‑week maintenance period, a final evaluation is performed.

    The total number of seizures during the observation periods after titration is compared with the baseline number to determine whether the study drug reduced seizure frequency.

    The final child behavior checklist is completed, and the overall safety profile, including any side effects, is recorded.

    The study drug is stopped, and the participant returns to usual care under the guidance of their regular physician.

Who can join the trial?

15 criteria

  • Both parents (or the single parent, if applicable) must sign and date a informed consent form, which shows they agree to let their child join the study.
  • The child must have tried at least four different anti‑seizure medications—either one at a time or in combination—at the correct doses, and the seizures are still not controlled.
  • The child must have daytime seizures that cause loss of consciousness and/or lead to falls, and/or nighttime seizures that turn the skin bluish (called cyanotic seizures).
  • The child must have an average of at least three seizures each month.
  • The child must be taking fewer than five anti‑seizure medications at the time of joining the study.
  • The doses of these medications must have been unchanged (a stable dose) for at least one week before the screening visit.
  • If the child is a girl who could become pregnant (childbearing potential), she must agree to use a highly effective contraceptive method throughout the study and for six weeks after the study ends.
  • The child must have no plan for, no medical reason against (contra‑indication), and no previous successful or refused epilepsy surgery.
  • The child must be able to take medicines by mouth (oral medication).
  • The child must be covered by a social security scheme or similar health insurance program.
  • Both parents (or the single parent) must agree to follow all study procedures for the entire duration of the study.
  • The child must be between 8 and 17 years old.
  • The child must give personal agreement to join the research, known as assent.
  • The child must have a rare or complex type of epilepsy, such as Developmental and Epileptic Encephalopathy, severe structural epilepsy, or other rare syndromes as defined by the International League Against Epilepsy.
  • The child must have drug‑resistant focal or generalized epilepsy according to the definition set by the International League Against Epilepsy.

Who cannot join the trial?

16 criteria

  • Participating in another clinical trial.
  • Unable to give consent and no legal representative is present to provide consent.
  • Having a known QT prolongation (a heart rhythm problem that can cause dangerous beats).
  • Having a past history of mania or hypomania (periods of unusually high mood and energy).
  • Taking oral anticoagulants (blood‑thinning medicines).
  • Having a bleeding disorder (a condition that makes it hard for blood to clot).
  • Having diabetes (a disease that affects blood sugar).
  • Having galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption syndrome (trouble digesting certain sugars).
  • Being pregnant or breastfeeding.
  • Weighing less than 20 kg at the screening visit.
  • Using a monoamine oxidase inhibitor (a type of antidepressant) or metoprolol (a heart medication) at the same time.
  • Having any problem with renal, hepatic, or cardiac function (kidney, liver, or heart problems).
  • Having treated or untreated high blood pressure (hypertension).
  • Scoring 23 or higher on the Neurological Disorders Depression Inventory‑Epilepsy for Youth scale or having any suicidal thoughts.
  • Being allergic to fluoxetine or any of its inactive ingredients.
  • Not speaking French well enough to understand the study (limited French proficiency).
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Investigated drugs

Fluoxetine
Fluoxetine is a medication that belongs to a group called selective serotonin reuptake inhibitors (SSRIs). It is usually used to treat depression, but in this study it is being added to the children’s regular epilepsy medicines to see if it can help lower the number of seizures they have. The drug works by increasing the level of serotonin, a chemical messenger in the brain, which may help calm the brain’s electrical activity that leads to seizures. Participants take fluoxetine by mouth while they continue their usual seizure medicines, and the researchers compare how often seizures happen with fluoxetine versus a placebo. Anti‑seizure treatment as usual (TAU)
Anti‑seizure treatment as usual refers to the standard epilepsy medicines that each child is already taking before the study begins. These can include common drugs such as carbamazepine, valproate, levetiracetam, or other medications prescribed by their doctors to control seizures. In the trial, children keep using their regular anti‑seizure medicines throughout the study, and the researchers add either fluoxetine or a placebo on top of this existing therapy to see if the added medication makes a difference in seizure frequency.

What is already known about the treatment

  • Cellulose microcristalline

    This inert powder is used as a placebo and is taken orally in the same form as the active drug, usually as a tablet or capsule. It has no therapeutic effect and is widely used in medicine as an excipient to give shape to pills. Because it contains no active ingredient, it has no mechanism of action and is not listed for any medical condition. It is classified simply as a pharmaceutical filler or excipient.

  • Fluoxetine

    Fluoxetine is taken by mouth as a 40 mg tablet and is added to the regular anti‑seizure medicines in the study. It is an approved medication for conditions such as depression and obsessive‑compulsive disorder and is being tested here as an add‑on for drug‑resistant epilepsy in children. The drug works by blocking the reuptake of serotonin, which raises serotonin levels in the brain and helps stabilize nerve activity. Pharmacologically, fluoxetine belongs to the class of selective serotonin reuptake inhibitors (SSRIs).

Investigated diseases

Drug-resistant epilepsy - Drug-resistant epilepsy is a type of epilepsy where seizures continue despite the use of two appropriate anti‑seizure medicines at adequate doses. It commonly begins in childhood and can involve many different seizure types. Seizures tend to occur repeatedly and may become more frequent over time. The condition can affect a child's daily activities and learning. The pattern of seizures often remains stable but can fluctuate, with occasional periods of increased intensity or new seizure types.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519897-38-01Protocol codePHRC-21-0282Estimated enrolment100 patientsSponsorCentre Hospitalier Regional De Marseille

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