A Study of Endoxifen in Patients.
- Conditions
- Health Condition 1: F318- Other bipolar disorders
- Registration Number
- CTRI/2022/01/039212
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female patients, 18 to 65 (both inclusive) years of age 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.2.Patients must have a diagnosis of bipolar I disorder and currently display manic episodes with or without mixed features according to DSM-5 criteria as judged by the Investigator.3.Young Mania Rating Scale (YMRS) total score range of more than or equal to 20 to less than or equal to 32 and more than or equal to 4 on two of four core items(irritability, speech, content, disruptive/aggressive behavior) at screening and at baseline(enrollment).4.Score of more than or equal to 4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP)Scale for overall illness at screening and at baseline (enrollment).5.Last intake of the medication(s) for BPD should be 2-7 days prior to enrolment depending upon the individual drug plasma half-life.6.Patient and / or LAR understand and agree to comply with all the study requirements.7.Male patients of child begetting potential must be practicing adequate contraception.8.Females of reproductive potential (which include girls who have entered puberty and all women who have a uterus and ovaries and have not achieved menopause), must use an acceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least one month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. For this study, acceptable and effective methods of contraception include-Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1-Intrauterine Device (IUD)-Estrogen-containing hormonal contraceptives-Progestin implant (i.e. Implanon or its equivalent-Progestin injection or progestin oral contraceptive pill plus one barrier method (cervical cap,diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom) -Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom)-Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).Note-Two forms of contraceptive methods should be used by female patients of child-bearing potential.In case of postmenopausal females(Menopause is the permanent end of menstruation and fertility),menopause should be clinically confirmed by a patient healthcare provider.Females who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy),need not use the contraceptive measures specified above for females of reproductive potential.The investigator should ensure that the patient is using two effective methods of avoiding pregnancy as per protocol.9.Female patients must not be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at enrolment.10.Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period.11.Patients not having any significant diseases or clinically significant abnormal findings except BPD during screening-including medical histor
1.Newly diagnosed patients and not having any suitable treatment exposure in past for their bipolar mood disorder.
2.More than or equal to 20 percent improvement in YMRS total scores between screening and enrolment visits.
3.Patients who meet DSM-5 criteria for any psychiatric disorder other than Bipolar I Disorder with manic episode with or without mixed features.
4.Patients with seizure disorder.
5.Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder
6.Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study
7.Patients with classical premenopausal symptoms found at risk of developing intolerable hot flushes,irregular vaginal bleeding.
8.Use of the following medications:
-Antihypertensive agents if stable dose has not been administered for at least 1 month before
enrolment
-Antidepressants in the week (or a period of 7 half-lives of the drug) prior to enrolment
-Continuous daily or standing orders use of benzodiazepines (in excess of 4 mg/day of lorazepam,or the equivalent) during the month preceding screening (approximately 5 weeks prior to screening)
-Depot antipsychotic medications within 1 dosing interval prior to enrolment
-Use of systemic estrogens 6 weeks prior to enrolment
-Patients currently on carbapenem agents
9.Any of the following laboratory abnormalities
-Serum bilirubin more than or equal to 1.5 times ULN
-Serum AST/ALT more than or equal to 2.5 times ULN
-Serum TSH more than 10percent above the ULN, regardless of treatment for hypothyroidism or
hyperthyroidism
-Serum triglyceride level more than 2.5 times ULN
-estimated Glomerular Filtration Rate (eGFR) of less than 60 mL/min/m2 by Modified Diet in Renal
Disease (MDRD) formula
10.Patients with the following cardiac conditions are excluded:
-History of Myocardial infarction
-QTc prolongation (screening electrocardiogram with QTc more than 450 msec for men, QTc more than 470 msec for women)
-History of QTc prolongation or using concomitant medications (as judged by the Investigator) which prolong QTc interval
-Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia
-De compensatory congestive heart failure
-Complete left bundle branch block
-First-degree heart block with PR interval more than 0.22 seconds
11.Presence of a coagulation disorder,active or past history of venous thromboembolism including deep venous thrombosis or pulmonary embolism.
12.Current prolonged immobilization.
13.History or current presence of retinal pathology including retinal vein thrombosis
14.History of Stroke or increased risk of stroke as per the Investigator discretion.
15.History of hypersensitivity or intolerance to tamoxifen or any other ingredients of the preparation.
16.Serious, unstable clinically significant illnesses including hepatic, renal, gastroenterologic,respiratory, cardiovascular (including ischemic heart disease),endocrinologic, neurologic,immunologic, or hematologic disease as per history and medical examination in opinion of
Investigator judgement.
17.Drug screen positive for any drug of abuse at screening (with the exception of benzodiazepines used in therapeutic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For primary outcome, time point is : All treatment related adverse events including abnormal laboratory parameters will be evaluated from the time of first study drug administration till end of study (i.e. from visit 2 to visit 13).Timepoint: All treatment related adverse events including abnormal laboratory parameters will be evaluated from the time of first study drug administration till end of study (i.e. from visit 2 to visit 13)
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of Endoxifen for the treatment of bipolar I disorder with mania/ manic episodes with or without mixed features.Timepoint: -Mean change from baseline to each subsequent visit and at end-of-study in total YMRS score <br/ ><br>-Proportion of patient achieving remission as per YMRS score (more than or equal to 12) at each postbaseline <br/ ><br>visit and at End-of-Study <br/ ><br>-Change in Clinical Global Impression-Bipolar (CGI-BP) score from baseline to <br/ ><br>each post-baseline visit and at End-of-Study <br/ ><br>-Mean change from baseline to at each post-baseline visit and at End-of-Study in Montgomery-Ã?â?¦sberg Depression Rating Scale (MADRS) score