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Study on the Effectiveness and Safety of Endoxifen for Adults with Bipolar I Disorder Experiencing Acute Mania or Manic Episodes

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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 Endoxifen in patients with Bipolar I Disorder. Bipolar I Disorder is a mental health condition characterized by extreme mood swings, including episodes of mania, which is a state of high energy and activity. The study aims to evaluate how effective and safe Endoxifen is in treating adults experiencing acute manic episodes, which may or may not include mixed features, such as symptoms of both mania and depression.

Participants in the study will receive either Endoxifen or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be "double-blind," meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of 21 days, during which participants will take the medication orally in the form of tablets.

The main goal of the study is to observe changes in the severity of manic symptoms from the beginning to the end of the study period. This will be measured using a scale called the Young Mania Rating Scale (YMRS), which helps assess the severity of manic episodes. Additionally, the study will look at other factors, such as overall improvement in mood and any changes in depression symptoms. The results will help determine if Endoxifen is more effective than the placebo in managing symptoms of Bipolar I Disorder during acute manic episodes.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study and understand what it involves. A close family member may also need to provide consent.
You will be assessed to ensure you meet the study's criteria, which includes being between 18 and 65 years old if male, or postmenopausal if female, and having a diagnosis of bipolar I disorder with acute manic episodes.
Step 2
Initial assessment
An initial assessment will be conducted, including a review of your medical history, a physical examination, and various tests such as blood tests, an ECG (a test that checks your heart's rhythm), and a chest X-ray.
You will also be evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Bipolar (CGI-BP) scale to assess the severity of your symptoms.
Step 3
Randomization
You will be randomly assigned to receive either the study medication, endoxifen, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
This process is double-blind, meaning neither you nor the study staff will know which treatment you are receiving.
Step 4
Treatment period
You will take the assigned tablets orally once a day. If you are in the endoxifen group, the dosage will be 8 mg per day.
The treatment period lasts for 21 days, during which you will be monitored closely for any changes in your condition and any side effects.
Step 5
Monitoring and assessments
Throughout the study, your symptoms will be regularly assessed using the YMRS and CGI-BP scales, among others.
You may also be asked about any feelings of depression or suicidal thoughts using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Step 6
End of treatment
At the end of the 21-day treatment period, a final assessment will be conducted to evaluate the effects of the treatment.
The study will measure changes in your symptoms and overall condition to determine the effectiveness of the treatment.

Who can join the trial?

12 criteria

Male patients aged 18 to 65 years and postmenopausal female patients can participate. Postmenopausal means having no menstrual periods for 12 months without another medical reason.
Participants must agree not to take any medications or therapies that are not allowed by the study rules.
Participants should not have any significant diseases or abnormal medical findings, except for Bipolar I Disorder, that could affect their safety or the study results.
Participants should not be at serious risk of suicide or harming others, as determined by clinical evaluation.
Female participants must have had no menstrual periods for six months with specific hormone levels, or have had surgery to remove both ovaries at least six months ago.
Participants must have a diagnosis of Bipolar I Disorder and currently be experiencing acute manic episodes, with or without mixed features, as per DSM-5 criteria.
Participants must have a Young Mania Rating Scale (YMRS) total score of more than 25 and a score of 4 or more on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at the start of the study.
Participants must have a score of more than 4 in the Severity of Illness criteria of the Clinical Global Impressions-Bipolar Disorder (CGI-BP) Scale at screening and at the start of the study.
Participants must be ready for voluntary hospitalization for the current manic episode for at least 2 days before starting the study treatment, up to 21 days of in-patient treatment.
The last intake of medication for Bipolar I Disorder should be 2-7 days before starting the study, depending on the medication.
Participants and their legally acceptable representative must understand and agree to follow all study requirements.
Male participants who can father children must use highly effective contraception, and their female partners must agree to this as well. Documentation is needed for male participants who have had surgical sterilization.

Who cannot join the trial?

5 criteria

Patients who do not have a diagnosis of Bipolar I Disorder cannot participate.
Patients who are not experiencing Acute Mania or Manic episodes cannot participate. Acute Mania refers to a period of extremely high energy, mood, and activity levels.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are part of a vulnerable population are not excluded, meaning the study does not specifically exclude groups that might need special protection.

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Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
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Bucharest, Romania

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Investigated drugs

Endoxifen is a medication being studied for its potential to help people with Bipolar I Disorder, particularly those experiencing episodes of extreme mood changes, known as mania. In this clinical trial, researchers are looking at how well Endoxifen works in reducing the symptoms of mania, which can include feeling overly excited, having lots of energy, or being unusually irritable. The goal is to see if Endoxifen can help stabilize these mood swings and improve the overall well-being of patients.

4-Hydroxy-N-Desmethyltamoxifen

What is already known about the treatment

Endoxifen – Endoxifen is administered orally in the form of a pill and is currently being studied for its effectiveness in treating Bipolar I Disorder, specifically targeting acute manic episodes. It is in the clinical trial phase, where researchers are evaluating its safety and efficacy compared to a placebo. The main therapeutic use of Endoxifen is to help manage symptoms of mania in individuals with Bipolar I Disorder. At the molecular level, Endoxifen works by modulating the activity of certain receptors in the brain, which can help stabilize mood. It is classified pharmacologically as a selective estrogen receptor modulator (SERM).

Investigated diseases

Bipolar I Disorder – Bipolar I Disorder is a mental health condition characterized by extreme mood swings that include emotional highs, known as mania or manic episodes, and lows, known as depression. During manic episodes, individuals may experience elevated mood, increased energy, reduced need for sleep, and impulsive behavior. These episodes can last for a week or more and may significantly impact daily functioning. Depressive episodes, on the other hand, involve feelings of sadness, hopelessness, and a lack of interest in activities once enjoyed. The disorder often begins in late adolescence or early adulthood and can vary in intensity and duration. It is a chronic condition that requires ongoing management to help stabilize mood swings.