Health Condition 1: F319- Bipolar disorder, unspecified
Conditions
Interventions
Intervention1: Endoxifen Enteric coated Tablet (8 mg) manufactured by Intas Pharmaceuticals Limited, India: Dose: 8 mg
Duration of treatment:
22 days
Control Intervention1: Divaa® OD(divalproex sodium extended release) Tablet 1000 mg manufactured by Intas Pharmaceuticals Limited.: Dose: 1000 mg
Duration of treatment:
22 days
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 an acute manic episodes with or without mixed features according to DSM-5criteria as judged by the Investigator. 3. Young Mania Rating Scale (YMRS) total score of > 20 and >=4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline) 4. Score of >4 in Severity of illness criteria of Clinical Global Impressionsbipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline). 5. Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode2 days prior to randomization up to 21 days of in-patient treatment period. 6. Previously treated with at least one of the following drugs: lithium, valproate, carbamazepine or an atypical (except for clozapine) or typical antipsychotic and found responsive to the same. 7. Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drugâ??s plasma half-life. 8. Patient and / or LAR understand and agree to comply with all the study requirements. 9. Male patients of child begetting potential and female patients of child bearing potential must be practicing adequate contraception. 10. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed patients not having any suitable treatment exposure in past for their bipolar mood disorder. 2. >= 20% improvement in YMRS total scores between screening and randomization visits. 3. Patients who meet DSM-5criteria for any psychiatric disorder other than Bipolar I Disorder with Acute manic episodes 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. History of retinal pathology including retinal vein thrombosis 8. Patients with classical premenopausal symptoms found at risk of developing intolerable hot flushes, irregular vaginal bleeding. 9. Presence of a coagulation disorder; active or past history of venous thromboembolism including deep venous thrombosis or pulmonary embolism 10. Current prolonged immobilization 11. History of current presence of retinal pathology including retinal vein thrombosis 12. Increased risk of stroke as per the Investigatorâ??s discretion 13. History of hypersensitivity or intolerance to tamoxifen, or any other ingredients of the preparation 14. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease as per history and medical examination. 15. Drug screen positive for any drug of abuse at screening, active substance abuse in the past 2 months or history of substance dependence (excluding nicotine and caffeine) within 3 months of screening. 16. History of breast or uterine cancer, or abnormal uterine bleeding. 17. Current leukopenia or thrombocytopenia as judged by the Investigator in the best health interest of the subject. 18. Clinically significant suicidal or homicidal ideation. 19. Participation in a clinical trial of another investigational drug within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in total YMRS scoreTimepoint: Day 0 (baseline) to Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Clinical Global Impression-Bipolar (CGI-BP) score, Montgomery-Ã?sberg Depression Rating Scale (MADRS) score, Clinical Global Impression-Severity of Illness scale (CGI-S) score, Columbia-Suicide Severity Rating Scale (C-SSRS) score and evaluation of safetyTimepoint: Day 0 (baseline) to Day 21 | — |
Countries
India
Contacts
Public ContactMr Amin K Dobaria
Lambda Therapeutic Research Ltd
Outcome results
None listed