Efficacy and Safety of Lumateperone in Comparison to Quetiapine for the Treatment of Bipolar II Depressio

Phase 3

• Conditions: Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity

• Registration Number: CTRI/2023/10/058583
• Lead Sponsor: Sun Pharma Laboratories Limited SP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients with BMI of 18.5 to 35 Kg/m2 at Screening

2) Patients who meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for Bipolar II Depressive Disorder by a MINI International Neuropsychiatric Interview (MINI)

3) Women of childbearing potential must be non-lactating and have a negative urine pregnancy test at Screening and Randomization visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (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]

4) Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period). No sperm donation is allowed during the study period.

Exclusion Criteria

1) 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 II Disorder, including:

a) Bipolar I disorder

b) Schizophrenia or other psychotic disorder

c) 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)

d) Feeding or eating disorder

e) Primary diagnosis of obsessive-compulsive disorder

f) Personality disorder

g) Moderate or severe substance use disorder

h) Any other psychiatric condition that has been the main focus of treatment

2) The patient has received electroconvulsive therapy, vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the last 5 years or received more than 1 course of electroconvulsive therapy during the patient’s lifetime

3) The patient is considered a rapid cycler, defined by the occurrence of at least 6 major depressive, manic, hypomanic, or mixed episodes during the previous year

4) The patient is considered treatment-resistant

5) The patient is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study

6) 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

7) Patients using one of the following medications:

a) Received Lumateperone anytime in the past

b) Use of any strong or moderate cytochrome P450 3A4 inhibitor or inducer within 7 days prior to Randomization

c) Use of any short-acting anxiolytic medications within 1 week prior to Randomization or of long-acting anxiolytics within 5 half-lives prior to Randomization

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 Randomization, whichever is less, including, but not limited to:

i. Sedative hypnotics (except zolpidem as needed, no more than 3 times per week, allowed during the screening period and the first 2 weeks of the treatment period)

ii. Central opioid agonists/antagonists including tramadol

iii. Anticonvulsants

iv. Other psychiatric medications (e.g.: mood stabilizers, antipsychotics, antidepressants)

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. Immunosuppressants

viii. Dietary supplements, medical foods, or pharmaceuticals containing Omega-3 fatty acids, melatonin, St. John’s Wort, kava kava, Vitamin B12, folate (no L-methylfolate in current episode), or valerian root. (Note: Daily multivitamin use is not an exclusion)

8) Patient with clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, hematological, neurological, metabolic, psychiatric or other condition that might be detrimental to t

Study & Design

• Study Type: Interventional
• Study Design: Not specified