A study of Risperidone Long Acting Injection 25 Mg/ Vial In Patients Needing Treatment For Schizophrenia And/or Maintenance Therapy For Bipolar I Disorder
- Conditions
- Health Condition 1: F317- Bipolar disorder, currently in remissionHealth Condition 2: F20- Schizophrenia
- Registration Number
- CTRI/2022/05/042538
- Lead Sponsor
- Intas Pharmaceuticals Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply 1 Participants and their legally acceptable representative must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study in this protocol and is willing to participate in the study.2 Participant must be 18 to 65 (both inclusive) years of age inclusive, at the time of signing the informed consent.3 Participants who are medically stable on the basis of physical examination, medical history, and vital signs, and 12-lead ECG performed at screening and at randomization. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator 5 Participants with confirmed documented diagnosis of Schizophrenia or Bipolar I Disorder as per DSM-V 5 criteria4 at screening. If participants have been initially diagnosed with DSM IV criteria than diagnosis should be reconfirmed as per DSM V criteria according to standard institutional practice 6 Participants with either of following scenario supported by documented medical history at screening -who are already stabilized and tolerating on Risperidone long acting injection 25 mg once every two weeks (at least 2 doses) prior to randomization.-who are stable and tolerating on oral Risperidone and have been prescribed treatment with Risperidone long acting injection 25 mg once every two weeks as per the clinical judgment of the treating physician and will be initiating the treatment as per the approved prescribing information.-who are already receiving and tolerating on Risperidone long acting injection 25 mg once every two weeks (for less than 2 doses) prior to randomization.7 Participants having body weight at least 50 kg for male and 48 kg for female and body mass index (BMI) within the range [18.0 â?? 30.0] kg per m2 (both inclusive) at screening and at randomization.8 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-Is not a woman of childbearing potential (WOCBP)OR-Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 per cent per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 3 months, after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 3 months, after the last dose of study intervention The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative pregnancy test within 24 hours at screening and at randomization visit (before the first dose of study intervention) as applicable(serum or urine).-If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.-Additional requirements for pregnancy testing during and after study intervention The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy 9 Male participants are elig
Any potential participant who meets any of the following criteria will be excluded from participating in the study 1 History or current evidence of clinically significant moderate hepatic impairment(Child-Pugh class B or more)History of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.2 Known allergies, hypersensitivity, or intolerance to Risperidone, Paliperidone or to any excipients in study medications.3 Contraindications to the use of Risperdal Consta (risperidone) long acting injection.4 Participants with history or presence of neuroleptic malignant syndrome (NMS),tardive dyskinesia, dementia-related psychosis, mood disorders or seizure disorder and Parkinson disease as assessed by the investigator.5 Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.6 Had major surgery,(eg, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study NOTE Participants with planned surgical procedures to be conducted under local anesthesia may participate.7 History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti- HCV at Screening.8 History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.9 History of drug or alcohol abuse within 6 months before Screening or positive test result for alcohol or drugs of abuse including barbiturates, opiates, cocaine, cannabinoids, and amphetamines except for benzodiazepines which are permissible when supported by a prescription at Screening. 10 Patients with known cerebrovascular disease (e.g. stroke).11 Patients with poorly controlled diabetes mellitus (defined as failure to achieve appropriate HbA1c goal based on clinical guidelines despite diabetes self management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin or other patient-specific condition) at the time of screening.12 Patients with uncontrolled hypertension (systolic BP less than 150 mmHg per diastolic BP less than or equal to 100 mmHg) at the time of screening and randomization.13 Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg within one to three minutes of standing up) at the time of screening and randomization.14 History or presence of clinically significant hyperprolactinemia as determined by investigator due to causes other than antipsychotic drugs use at screening.15 QTc greater than 450 msec for male participants or QTc greater than 470 msec for female participants or QTc greater than 480 msec in participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia formula (QTcF). It is either machine-read or manually over-read. 16 Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 and CYP3A4 inhibitors or inducers, drugs known to prolong the QT interval detailed
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic profile <br/ ><br>and to assess the bioequivalence of <br/ ><br>Risperidone long acting injection 25 mg <br/ ><br>relative to Risperdal CONSTA® (Risperidone) long acting injection 25 mg in patients needing treatment for Schizophrenia and/or maintenance therapy for Bipolar I DisorderTimepoint: Following pharmacokinetic parameters will be evaluated for Risperidone in plasma: <br/ ><br>-On dose 7 and 14: Primary PK <br/ ><br>parameters: Cmax,ss and AUC0-t,ss
- Secondary Outcome Measures
Name Time Method