Health Condition 1: F31- Bipolar disorder
Conditions
Interventions
Intervention1: Lumateperone Capsules: One capsule should be taken orally once daily with food for 42 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Sun Pharma Laboratories Limited
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, age between 18 to 65 years (both inclusive), and willing to provide written informed consent 2. Patients with BMI of 18.5 to 35 Kg/m2 at Screening 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for Bipolar I or II Depressive Disorder (as per prior documents) 4. Patients taking Lithium or Valproate should be on a stable dose for at least 4 weeks prior to Screening with inadequate therapeutic response to depressive symptoms and without any signs of toxicity 5. Women of childbearing potential must be non-lactating and have a negative urine pregnancy test at Screening and Enrolment visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till study completion (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] 6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period). No sperm donation is allowed during the study period.
Exclusion criteria
Exclusion criteria: 1. Patient with known hypersensitivity to the study drugs or drugs of similar chemical classes or to any of its excipients 2. The patient has a history within 12 months prior to screening, based on previous psychiatric evaluation or a confirmed diagnosis upon screening based on the DSM-5, of a psychiatric diagnosis other than Bipolar I or II Disorder, including: a) Schizophrenia or other psychotic disorder b) Anxiety disorders such as panic disorder, general anxiety disorder, or post-traumatic stress disorder as a primary diagnosis (however, anxiety symptoms may be allowed, if secondary to Bipolar Disorder, provided these symptoms do not require current treatment) c) Feeding or eating disorder d) Primary diagnosis of obsessive-compulsive disorder e) Personality disorder f) Moderate or severe substance use disorder (excluding for nicotine) g) Any other psychiatric condition (other than Bipolar Disorder) that has been the main focus of treatment 3. The patient has been hospitalized for mania associated with Bipolar I Disorder within 30 days prior to screening 4. The patient has received electroconvulsive therapy, vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the last 5 years of Screening 5. The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma 6. Patients using one of the following medications: a) Lifetime exposure to Lumateperone (i.e., participated in previous clinical study with Lumateperone or previously received Lumateperone) b) Use of any strong or moderate cytochrome P450 3A4 inhibitor or inducer within 7 days prior to Enrolment visit (Note: Patients taking these medication(s) will require a 7 days washout period or a period equal to 5 half-lives of the medication (whichever is longer) prior to Enrolment visit) c) Use of any short-acting anxiolytic medications within 1 week prior to Enrolment visit or of long-acting anxiolytics within 5 half-lives prior to Enrolment visit (Note: Patients taking short-acting anxiolytic medication(s) will require a 7 days washout period and patients taking long-acting anxiolytics will require a washout period equal to 5 half-lives period of the medication prior to Enrolment visit) d) Medication(s) with known psychotropic properties or any non-psychotropic medication(s) with known or potentially significant central nervous system effects within the last 28 days or 5 half-lives prior to Enrolment visit, whichever is less, including, but not limited to: i. Sedative hypnotics (with the exception of lorazepam or zolpidem as needed, no more than 3 times per week, allowed during the screening period and the first 2 weeks of the treatment period); (Note: If lorazepam or zolpidem is not available in specific regions, another sedative hypnotic may be approved by the Medical Monitor) ii. Central opioid agonists/antagonists including tramadol iii. Anticonvulsants iv. Mood stabilizers, antipsychotics, antidepressants (except Lithium or Valproate) v. Methotrexate vi. Any known 5-HT2A receptor antagonist or inverse agonist including but not limited to mianserin, mirtazapine, nefazodone, cyproheptadine, pimavanserin, or fluvoxamine vii. Immunos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment emergent (TEAEs) and serious adverse events (SAEs)Timepoint: [Time frame: up to week 8] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in YMRS total scoreTimepoint: [Time frame: Baseline, Weeks 2, 4 and 6];Change from baseline in MADRS total scoreTimepoint: [Time frame: Baseline, Weeks 2, 4 and 6];Change from baseline in Quality-of-Life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) total scoreTimepoint: [Time frame: Baseline, Weeks 2, 4, and 6] | — |
Countries
India
Contacts
Public ContactVidya Sethumadhavan
Sun Pharma Laboratories Limited
Outcome results
None listed