This study is to checkthe Safety and Tolerability of Olanzapine/Samidorphan (5mg/10 mg 10 mg/10 mg 15 mg/10 mg and 20 mg/10 mg) in Adults with Schizophrenia and BipolarDisorder

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: FDC of Olanzapine/Samidorphan 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg: Participants will be randomized to receive one of the four dosages once daily for 24 weeks Control Intervention1: FDC of Olanzapine 5/10/15/20 mg + Placebo of Samidorphan 10mg: Participants will be randomized to receive one of the four dosages once daily for 24 week CONDITION: Health Condition 1: F209‐ Schizophrenia, unspecified Health Condition 2: F209‐ Schizophrenia, unspecified PRIMARY OUTCOME: Improvement in Positive and Negative Symptom Scale PANSS ; Improvement in YMRS Young Mania Rating scale ; Changes in the metabolic parameters fasting lipids profile fasting triglycerides low‐density lipoprotein high density lipoprotein total ; cholesterol HbA1c fasting plasma glucose post prandial glucose and fasting insulin body weight Body Mass Index and Waist circumferenceTimepoint: from baseline to 24 week SECONDARY OUTCOME: Percent change in body weight ; Percent change in body weight and the proportion of Participants who gained less than equal to 10 percent body weight ; Improvement in Clinical Global Impression Severity ; Improvement in Clinical Global Impression ; Impact of Weight on Quality of Life Lite Questionnaire ; Change in EuroQol‐5D EQ‐5D ; Proportion of Participants with greater than or equal to 7 percent weight gain ; Change in quality of life QoL scores using the WHOQOL‐BREF scaleTimepoint: from baseline to 24 week INCLUSION CRITERIA: Cohort 1 Schizophrenia Male or female participant who is willing and able to provide written informed consent Adults aged more than 18 years and less than 65 years diagnosed with schizophrenia Participant has a body mass inde XBMI above 1 and less than 30 kg per m square Meets the criteria for the DSM 5 diagnosis of schizophrenia confirmed with the Mini International Neuropsychiatric Interview MINI and is currently experiencing an acute exacerbation or relapse If screened as an inpatient the participant has been hospitalized for less than two weeks for the current exacerbation Total PANSS score of 80 or higher at screening and baseline Visits 1 and 2 in participants with schizophrenia A score of 4 or higher on at least three of the following PANSS Positive Scale items at Visits 1 and 2 in participants with schizophrenia Item 1 P1 delusions Item 2 P2 conceptual disorganization Item 3 P3 hallucinatory behavior Item 6 P
Epistemonikos ID: daaefe0b321a2d022eb40f6987abf3ef80377051
First added on: Oct 08, 2026