Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Aripiprazole 400 mg Powder and Solvent for Prolonged - Release Suspension for Injection: Dose - 400 mg
frequency - six doses
ROA â?? Injection
Total duration 4 Week
Control Interven
Sponsors
Laboratorios Liconsa SA
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female patient between 18 and 65 years of age (both inclusive). 2. Patient with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders â?? 5th edition (DSM-V) criteria. 3. Patient with Body Mass Index (BMI) >=18 to less than 30 kg/m2 and weight not less than 50 kg. 4. Patient who is clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms during the 3 months before screening and till randomization. 5. Patient is clinically stable on aripiprazole 10-20 mg for the past 3 months who require chronic antipsychotic treatment and who will benefit from initiating treatment with aripiprazole 400 mg powder and solvent for prolonged-release suspension for injection. 6. Patient and LAR must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing written informed consent. 7. Patient who agrees to comply with the visit schedule and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Patient with known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation. 2. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing, fatigue etc.) 3. History of medically significant adverse events or intolerance with aripiprazole based on investigators discretion. 4. Patient on drugs known to be inducer or inhibitor of CYP3A4 and CYP2D6 enzymes (allowed if on a stable regimen of at least 1 month based on Principal Investigators discretion) Note: a. If the patient was on any of these drugs, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug and the first dose of study medication. b. Individuals with co-administered weak CYP3A4 and CYP2D6 inhibitors will be allowed if on a stable regimen of at least 1 month based on Principal Investigatorâ??s discretion in consultation with medical monitor and with plans to remain on that stable regimen throughout the course of this study. 5. Patient who is poor metabolizer of CYP2D6 enzyme. 6. Patient with Clinical Global Impression â?? Severity of illness (CGIS) score of 5 or more. 7. Patient with inadequate muscle mass to receive the intramuscular injection according to the investigator. 8. Patient with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics. 9. Patient with dementia related psychosis. 10. History or presence of pathological gambling and other compulsive behaviors. 11. Patient with history or presence of seizures or other conditions that potentially lower the seizure threshold. 12. Presence of significant orthostatic hypotension (i.e., decrease in systolic blood pressure >=20 mmHg or diastolic BP of >=10 mmHg when comparing standing to supine values) or uncontrolled hypertension (systolic BP >=150 mmHg/diastolic BP >= 100 mmHg). 13. Patient with known cardiovascular disease (example, heart failure, history of myocardial infarction or ischemia), cerebrovascular disease, or conditions that predispose the patient to hypotension (example, dehydration, hypovolemia, and treatment with antihypertensive medications), uncontrolled metabolic disorders including uncontrolled hyperglycemia/diabetes mellitus (HbA1c >= 9 %) or Dyslipidemia. 14. Patient with a history of a corrected QT interval greater than 450 msec (Bazettâ??s formula) 15. History of drug induced leukopenia/neutropenia/agranulocytosis. 16. Patient with abnormal haematological parameters at screening and randomization defined by: a. Total white blood cell count less than 4000/mm3. b. ANC less than 1500/mm3. c. Platelet count less than 100,000/mm3. d. Haemoglobin less than 9.0 gm/dl. 17. Patient with abnormal liver function tests at screening and randomization as defined by: a. Bilirubin greater than 1.5 x ULN. b. AST and ALT greater than 5 x ULN. 18. History of alcohol or substance abuse in the immediate 6-month period prior to screening. 19. Patient who smokes or chews tobacco products. 20. Any changes in antipsychotic medication or dosage during the past 3 months prior to the randomization. 21. Received Electroconvulsive Therapy (ECT) within the last 3 months prior to screening. 22. Patient with suicidal i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalenceTimepoint: End of Study: Week 49 (Day 337) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerabilityTimepoint: End of Study: Week 49 (Day 337) | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed