Ongoing Clinical Trials for Bipolar I Disorder
Currently, there is 1 ongoing clinical trial investigating new treatment options for Bipolar I Disorder, specifically focusing on adults experiencing acute manic episodes. This trial is testing the effectiveness and safety of an investigational medication called Endoxifen, which may help stabilize mood swings and reduce symptoms of mania.
Clinical trial locations
Study on the Effectiveness and Safety of Endoxifen for Adults with Bipolar I Disorder Experiencing Acute Mania or Manic Episodes
This clinical trial is investigating a medication called Endoxifen for treating adults with acute manic episodes. The study is designed as a double-blind, placebo-controlled trial lasting 21 days, where participants will receive either Endoxifen tablets or a placebo once daily. The main goal is to measure changes in manic symptoms using the Young Mania Rating Scale (YMRS) and to assess overall improvement in mood and functioning.
Inclusion criteria: Participants must be male patients aged 18 to 65 years or postmenopausal female patients. All participants must have a confirmed diagnosis of Bipolar I Disorder and currently be experiencing acute manic episodes, with or without mixed features. At the time of screening and study start, participants must have a YMRS total score greater than 25 and score 4 or more on at least two of four core items measuring irritability, speech, content, and disruptive or aggressive behavior. They must also score more than 4 on the Severity of Illness criteria of the Clinical Global Impressions-Bipolar Disorder Scale. Participants need to be willing to stay in hospital for at least 2 days before treatment begins and throughout the 21-day treatment period. Prior medication for the condition must be stopped 2-7 days before study treatment begins. Male participants who can father children must use highly effective contraception.
Exclusion criteria: Patients without a confirmed diagnosis of Bipolar I Disorder cannot participate. Those not currently experiencing acute mania or manic episodes are also excluded. Participants must fall within the specified age range for the study. Patients with significant medical conditions or abnormal findings that could affect their safety or the study results are excluded, except for the diagnosis itself. Those at serious risk of suicide or harming others, as determined by clinical evaluation, cannot take part.
Study focus: The trial aims to evaluate how effective Endoxifen is in reducing symptoms of acute mania compared to placebo. Researchers will closely monitor changes in mood, energy levels, irritability, and other manic symptoms throughout the 21-day period. The study will also assess safety and tolerability of the medication, including any side effects that may occur.
Investigational drug: Endoxifen is being tested at a dosage of 8 mg per day, taken orally as tablets. Endoxifen is classified as a selective estrogen receptor modulator (SERM) and works by modulating the activity of certain receptors in the brain, which may help stabilize mood in people experiencing manic episodes.
Summary
Currently, there is one active clinical trial for Bipolar I Disorder, focusing specifically on adults experiencing acute manic episodes. This trial is taking place in Romania and is investigating Endoxifen, a medication that works differently from traditional mood stabilizers by modulating estrogen receptors in the brain. The trial uses rigorous assessment tools including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar Disorder Scale to measure treatment effectiveness. The study requires hospitalization for safety monitoring and careful evaluation of manic symptoms throughout the treatment period. This research represents an important step in exploring new treatment options for managing acute mania in people living with Bipolar I Disorder.
