Patient description: A 22-year-old Caucasian man came to the Clinic with a history of tremors since a year ago. The tremor was first in his right hand while holding something. Later the tremor became continuous and extended to both hands and legs and even at rest. The Kayser-Fleischer' ring was detected in the ophthalmologic exam. The physical exam revealed jaundice, hepatosplenomegaly and hypotonia of the upper limbs. He had a constant smile on his face, however, he has aggressive behavior according to his parents' explanation. His laboratory study was significant for a low serum caeruloplasmin (0.05 g/l), and a raised 24 hour urine copper excretion (120 μg/24 h). Wilson disease was confirmed by high liver copper concentration (305 μg/g dry weight of liver).

Clinical trial eligibility criteria: eligible ages (years): 18.0-65.0,  Bipolar I Disorder 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-5 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 of Clinical Global Impressions bipolar 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 episode 2 days prior to randomization up to 21 days of in-patient treatment period. 6. 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. 7. Patient and / or LAR understand and agree to comply with all the study requirements. 8. Male patients of child begetting potential must be practicing adequate contraception. 9. Females of reproductive potential (which girls who have entered puberty and all women who have a uterus and ovaries and have not completed menopause), must use anacceptable 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. 10. Subjects judged clinically not to be at serious suicide risk  Newly diagnosed patients and not having any suitable treatment exposure in the past for their bipolar mood disorder. 2. > 20% improvement in YMRS total scores between screening and randomization visits. 3. Patients who meet DSM-5 for any psychiatric disorder other than Bipolar I Disorder with Acute Mania 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 randomization Antidepressants in the week (or a period of 5 half-lives of the drug) prior to randomization Continuous daily or standing orders use of benzodiazepines during the month preceding screening (approximately 5 weeks prior to screening) Potent cytochrome P450 (CYP) inducers and CYP2D6/CYP3A4 inhibitors 14 days prior to randomization Depot antipsychotic medications within 1 dosing interval prior to randomization Use of systemic estrogens 6 weeks prior to randomization Patients currently on carbapenem agents 9. Any of the following laboratory abnormalities Serum bilirubin ≥ 1.5 times ULN Serum AST/ALT ≥ 2.5 times ULN