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4-Hydroxy-N-Desmethyltamoxifen

A groundbreaking clinical trial is underway to investigate the effectiveness and safety of 4-Hydroxy-N-Desmethyltamoxifen, also known as Endoxifen, in treating adults with Bipolar I Disorder experiencing acute mania or manic episodes. This Phase III study aims to evaluate the drug’s potential as a new treatment option for this challenging mental health condition. The trial involves a double-blind, placebo-controlled approach to assess Endoxifen’s efficacy and establish its superiority over placebo in managing manic symptoms.

Table of Contents

What is Endoxifen?

Endoxifen, also known by its chemical name 4-hydroxy-N-desmethyltamoxifen, is a medication currently being studied for the treatment of Bipolar I Disorder. It is classified as an antipsychotic and a nonsteroidal selective estrogen receptor modulator (SERM)[1]. Endoxifen is being developed as a tablet to be taken orally.

Medical Condition: Bipolar I Disorder

Bipolar I Disorder is a mental health condition characterized by episodes of mania (extremely elevated mood and energy) and depression. In this clinical trial, researchers are specifically focusing on patients experiencing acute mania or manic episodes, which may or may not include mixed features (symptoms of both mania and depression occurring simultaneously)[1].

How Endoxifen Works

While the exact mechanism of action for Endoxifen in treating Bipolar I Disorder is not fully explained in the provided information, it is known to be a selective estrogen receptor modulator. This means it can interact with estrogen receptors in the body, potentially influencing brain chemistry and mood regulation[1].

Clinical Trial Details

The clinical trial for Endoxifen is a Phase III study, which means it is in an advanced stage of testing. The main goal of this trial is to evaluate how effective and safe Endoxifen is for treating adults with Bipolar I Disorder who are experiencing acute mania or manic episodes[1].

Key details of the trial include:

  • It is a double-blind study, meaning neither the patients nor the researchers know who is receiving Endoxifen or a placebo.
  • Participants will be randomly assigned to either the Endoxifen group or the placebo group.
  • The dosage being tested is 8 mg of Endoxifen.
  • The treatment period lasts for 21 days.
  • Patients will be hospitalized for at least 2 days and up to 21 days during the treatment period[1].

Eligibility Criteria

To participate in this clinical trial, patients must meet specific criteria. Some key eligibility requirements include:

  • Male patients aged 18 to 65 years or postmenopausal female patients
  • Diagnosed with Bipolar I Disorder and currently experiencing acute manic episodes
  • A Young Mania Rating Scale (YMRS) total score of more than 25
  • Willing to be hospitalized for the treatment period
  • Not taking certain medications that could interfere with the study[1]

There are also several exclusion criteria, such as certain heart conditions, history of blood clots, or other serious health issues. It’s important to discuss all medical history with the study team to determine eligibility[1].

Potential Benefits

The researchers hope to see improvements in several areas, including:

  • Reduction in manic symptoms, as measured by the Young Mania Rating Scale (YMRS)
  • Improvement in overall bipolar disorder symptoms, assessed using the Clinical Global Impression-Bipolar (CGI-BP) scale
  • Reduction in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Decreased need for additional medications to control agitation or anxiety[1]

Safety Considerations

As with any clinical trial, patient safety is a top priority. The researchers will be monitoring several aspects of participants’ health, including:

  • Heart health, including any changes in heart rhythm
  • Risk of blood clots
  • Liver function
  • Thyroid function
  • Mental health, including any thoughts of self-harm or suicide[1]

It’s important to note that Endoxifen is still being studied, and not all potential side effects may be known. Patients considering participation in this trial should discuss the potential risks and benefits with their healthcare provider and the study team[1].

Aspect Details
Drug Name 4-Hydroxy-N-Desmethyltamoxifen (Endoxifen)
Trial Phase Phase III
Condition Studied Bipolar I Disorder with Acute Mania/Manic Episodes
Study Design Double-blind, oral, placebo-controlled, multiple-dose, parallel, randomized
Primary Objective Evaluate efficacy and establish superiority of Endoxifen 8 mg against placebo
Treatment Duration 21 days
Primary Endpoint Mean change from baseline to Day 21 on YMRS Total Score
Key Inclusion Criteria Adults 18-65, YMRS score >25, CGI-BP score >4
Key Exclusion Criteria Certain cardiac conditions, active substance abuse, suicidal/homicidal ideation
Safety Assessments Adverse events, laboratory tests, ECG, C-SSRS

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the efficacy and establish the superiority of Endoxifen 8 mg against placebo in treating adult patients with Bipolar I Disorder experiencing acute mania or manic episodes, with or without mixed features.
  • Who is eligible to participate in this study? Eligible participants include males aged 18-65 and postmenopausal females with a diagnosis of Bipolar I Disorder, currently displaying acute manic episodes. They must have a Young Mania Rating Scale (YMRS) total score of >25 and meet specific criteria regarding their condition's severity.
  • What is the duration of the treatment in this trial? The treatment period in this trial lasts for 21 days, during which participants will be hospitalized for a minimum of 2 days prior to randomization and up to 21 days of in-patient treatment.
  • What are some of the exclusion criteria for this study? Some exclusion criteria include newly diagnosed patients without past treatment exposure, certain cardiac conditions, history of breast or uterine cancer, active substance abuse, and clinically significant suicidal or homicidal ideation.
  • How will the effectiveness of Endoxifen be measured? The primary measure of effectiveness will be the mean change from baseline to Day 21 on the YMRS Total Score. Secondary measures include the percentage of patients with ≥50% improvement in YMRS score, changes in CGI-BP and MADRS scores, and the need for rescue medications.

Ongoing Clinical Trials on 4-Hydroxy-N-Desmethyltamoxifen

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

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Romania

Glossary

  • Bipolar I Disorder: A mental health condition characterized by alternating episodes of mania (extreme highs) and depression (extreme lows). In Bipolar I, manic episodes are severe and last at least 7 days.
  • Endoxifen (4-Hydroxy-N-Desmethyltamoxifen): An active metabolite of tamoxifen, being studied as a potential treatment for Bipolar I Disorder. It is classified as a nonsteroidal selective estrogen receptor modulator (SERM).
  • Young Mania Rating Scale (YMRS): A rating scale used to evaluate manic symptoms in patients with bipolar disorder. It measures the severity of symptoms such as elevated mood, increased motor activity, and irritability.
  • Clinical Global Impressions-Bipolar (CGI-BP) Scale: A tool used by healthcare professionals to assess the overall severity of bipolar disorder symptoms and track changes in a patient's condition over time.
  • Montgomery-Åsberg Depression Rating Scale (MADRS): A questionnaire used to measure the severity of depressive episodes in patients with mood disorders, including bipolar disorder.
  • Columbia-Suicide Severity Rating Scale (C-SSRS): A series of questions used to assess suicide risk in clinical trials and general practice.
  • Double-blind study: A research design where neither the participants nor the researchers directly involved know who is receiving the experimental treatment and who is receiving a placebo or standard treatment.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect, used as a control in clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-endoxifen-for-adults-with-bipolar-i-disorder-experiencing-acute-mania-or-manic-episodes/