Health Condition 1: F319- Bipolar disorder, unspecified
Conditions
Interventions
Intervention1: Endoxifen: 4 mg tablet in Stage I and 8 mg tablet in Stage II Orally Once Daily on Day 0 till 21 days
Control Intervention1: Divaa®: Tablet Divaa® Orally (Divalproex Sodium Extended R
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must have a diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features) according to DSM-IV-TR as judged by the Investigator. 2. Patients willing to give written informed consent along with at least one first degree relative/the legally acceptable representative (LAR). 3. Young Mania Rating Scale (YMRS) total score of > 20 and a score of > 4 on Clinical Glogal Impressions of Severity (CGI â?? S) Scale at screening and at randomization (baseline). 4. Ready for voluntary hospitalization for the current manic/mixed episode 2 day prior to randomization throughout the active treatment period. 5. Previously treated with at least one of the following drugs at some time during the course of their bipolar illness: lithium, valproate, carbamazepine, or an atypical (except for clozapine) or typical antipsychotic. 6. Patients of child begetting potential must be practicing adequate contraception. 7. Subjects free of co-morbid substance abuse or dependence for at least one month and judged clinically not to be at serious suicide risk.
Exclusion criteria
Exclusion criteria: 1. Treatment naïve patients 2. > 20% improvement in YMRS total scores between screening and randomization visits. 3. Presence of a coagulation disorder; active or past history of venous thromboembolism including deep venous thrombosis or pulmonary embolism. 4. Patients having any significant diseases or clinically significant abnormal findings except BPD during screening-including medical history, physical examination, laboratory evaluations, 12-lead ECG recording, X-ray chest examination, etc. which is likely to adversely affect patient safety by participating in the study or study objectives in opinion of Investigator. 5. Concomitant Use with Systemic Estrogens. 6. Hypertriglyceridemia (S.tg level > 200 mg/dL). 7. Patients who meet DSM-IV-TR criteria for any psychiatric disorder other than bipolar I disorder with current mixed/manic episode as per discretion of Investigator. 8. Patients with seizure disorder. 9. Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder in need of treatment. 10. Patients with borderline or antisocial personality disorder. 11. Last intake of an antidepressant medication within 4 weeks prior to study entry. 12. A history of hypersensitivity or intolerance to tamoxifen, divalproex sodium or any other ingredient of the preparation. 13. Clinically significant suicidal or homicidal ideation. 14. Participation in a clinical trial of another investigational drug within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders in each arm based on Young Mania Rating Scale (YMRS) total scoreTimepoint: on Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Clinical Global Impression-Severity of Illness Scale (CGI-S)Timepoint: From Baseline to EOT;Mean change in Columbia-Suicide Severity Rating Scale (C-SSRS)Timepoint: From Baseline to EOT;Mean change in Montgomery- Ã?sberg Depression Rating Scale (MADRS)Timepoint: From Baseline to EOT;Safety and Adverse Event ProfileTimepoint: Throughout | — |
Countries
India
Contacts
Public ContactDr Randhirsinh Solanki
Lambda Therapeutic Research Ltd
Outcome results
None listed