Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients (NCT06608641) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
United States490 participantsStarted 2024-03-19
Plain-language summary
Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male ≥18 to ≤65 years of age and postmenopausal female patients (12 months with no menses without an alternative medical cause) willing to give written informed consent along with at least one first degree relative (the legally acceptable representative \[LAR\]) to participate in the study before initiating any study related procedures.
✓. Six months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL; OR have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of child-bearing potential.
✓. Patients must have a diagnosis of bipolar I disorder and currently display an acute manic episode with or without mixed features according to DSM-5 criteria as judged by the Investigator.
✓. Young Mania Rating Scale (YMRS) total score of \> 25 and ≥4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline). The optimal YMRS23 severity threshold of 25 was chosen as this corresponds to a Positive Predictive Value (PPV) of 83%, signifying that 83% of patients with a baseline score ≥ 25 are at least "Markedly ill".
✓. Score of \>4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline).
✓
What they're measuring
1
Efficacy - mean change from baseline to Day 21 in the total YMRS score
. Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode for a minimum of 2 days prior to randomization through 21 days of in-patient treatment period.
✓. Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drug's plasma half-life.
✓. Patient and / or LAR understand and agree to comply with all the study requirements.
Exclusion criteria
✕. Newly diagnosed patients not having any suitable treatment exposure in the past for their bipolar mood disorder.
✕. ≥ 20% improvement in YMRS total scores between screening and randomization visits.
✕. Patients who meet DSM-5criteria for any psychiatric disorder other than Bipolar I Disorder with Acute manic episodes with or without mixed features
✕. Patients with seizure disorder
✕. Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder
✕. Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study
✕. Patients with classical premenopausal symptoms were found at risk of developing intolerable hot flushes, irregular vaginal bleeding.