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Study on the Effects of Low-Dose Acetylsalicylic Acid in Patients with Bipolar 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 is focused on studying the effects of a medication called low-dose aspirin in patients with bipolar disorder. Bipolar disorder is a mental health condition characterized by extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). The study aims to evaluate how effective and safe low-dose aspirin is when added to the standard treatment that patients with bipolar disorder are already receiving.

Participants in the study will be randomly assigned to receive either low-dose aspirin or a placebo, which is a substance with no active medication. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the aspirin or the placebo, ensuring unbiased results. The study will last for a total of 12 months, with regular check-ins to monitor the participants' progress and any changes in their condition.

The main goal is to see if adding low-dose aspirin can help improve symptoms of depression in bipolar disorder and prevent future episodes. The study will also look at the overall safety of using aspirin in this way. Participants will be assessed using various scales to measure their mood and general functioning throughout the study period. This research could provide valuable insights into new ways to manage bipolar disorder effectively.

The research process

The trial runs in 5 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 diagnosis of bipolar disorder is confirmed by a physician based on clinical history and specific criteria.

    Eligibility is determined by age (18-60 years), current treatment with mood stabilizers (excluding valproates), and the ability to provide informed consent.

    Women of childbearing age must have a negative pregnancy test and agree to use effective contraception.

  2. Step 2

    Initial treatment phase

    The study involves taking a low-dose of acetylsalicylic acid (150 mg per day) in the form of a gastro-resistant tablet called Polocard.

    The medication is taken orally as an add-on to the standard therapy for bipolar disorder.

  3. Step 3

    Short-term intervention

    The initial phase lasts for 2 months, focusing on treating a depressive episode.

    The effectiveness is measured by changes in the Hamilton scale (HAMD-17) score after 2 months.

    Secondary outcomes include remission rates and improvement in clinical impression and general functioning.

  4. Step 4

    Long-term intervention

    The long-term phase aims to prevent relapse over 12 months.

    Evaluations occur at 4, 6, and 12 months, assessing relapse rates and changes in clinical impression and functioning.

    The study also monitors the frequency of suicide attempts during this period.

  5. Step 5

    Completion of study

    The study is estimated to conclude by April 30, 2026.

    Final assessments will determine the overall efficacy and safety of the treatment.

Who can join the trial?

7 criteria

  • The patient must have a diagnosis of bipolar disorder, which will be confirmed by a doctor based on medical history and specific criteria.
  • The patient is currently experiencing a depressive episode, which is a period of low mood and other symptoms.
  • The patient must be between the ages of 18 and 60, and both women and men can participate.
  • The patient is currently being treated with at least one mood stabilizer, which is a type of medication used to help manage mood swings in bipolar disorder, but not with valproates.
  • The patient must be able to understand the study and agree to participate by giving informed consent.
  • The patient's body mass index (BMI) should be between 18 and 40. BMI is a measure of body fat based on weight and height.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use highly effective birth control methods during the study. This is important because some medications, like carbamazepine, can make hormonal birth control less effective.

Who cannot join the trial?

9 criteria

  • Individuals who are not diagnosed with Bipolar Affective Disorder cannot participate. This is a mental health condition that causes extreme mood swings.
  • Participants must be within a specific age range, typically adults, to be eligible.
  • Both males and females are eligible, but certain gender-specific conditions may exclude participation.
  • Individuals who are part of a vulnerable population, such as those unable to give informed consent, may be excluded.
  • Participants must not have any medical conditions that could interfere with the study or pose a risk to their health.
  • Individuals currently taking medications that could interact with the study treatment may be excluded.
  • Pregnant or breastfeeding women are usually excluded to avoid any potential risks to the baby.
  • Participants must not have a history of allergic reactions to the study medication or similar drugs.
  • Individuals with a history of substance abuse may be excluded to ensure the safety and accuracy of the study results.
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Investigated drugs

Aspirin is being studied as an additional treatment for patients with bipolar disorder. It is commonly used to relieve pain, reduce inflammation, and lower fever. In this trial, it is being tested to see if it can help improve the symptoms of bipolar disorder when added to the usual treatments.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is currently being studied in clinical trials as an add-on treatment for bipolar disorder, alongside standard therapy. The main therapeutic indication in this context is to evaluate its efficacy and safety in managing symptoms of bipolar disorder. At the molecular level, aspirin works by inhibiting enzymes involved in the production of substances that promote inflammation and pain, which may also influence mood regulation. It is classified pharmacologically as a non-steroidal anti-inflammatory drug (NSAID).

Investigated diseases

Bipolar Affective Disorder – This is a mental health condition characterized by extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). During a depressive episode, individuals may feel sad, hopeless, and lose interest in most activities. In contrast, a manic episode can involve feelings of euphoria, increased energy, and sometimes irritability. These mood swings can affect sleep, energy, activity, judgment, behavior, and the ability to think clearly. The disorder typically progresses with alternating episodes of mania and depression, which can vary in duration and intensity. Over time, the frequency and severity of these episodes can change, impacting daily life and functioning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516584-86-00Protocol codeIPIN/ASPIRIN/BDEstimated enrolment100 patientsSponsorInstytut Psychiatrii I Neurologii

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