Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Quetiapine: Quetiapine 400gm Extended Release Tablets
Control Intervention1: Seroquel XR®: Quetiapine 400 mg Extended Release Tablets
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Schizophrenic patients, between 18 and 60 years of age (inclusive) and having a Body Mass Index (BMI) between 18 and 30 (inclusive), calculated as weight in kg / height in m2. 2. Patient has a documented clinical diagnosis of schizophrenia (DSM IV-TR) on a stable dose of Quetiapine 400 mg per day for at least 10 days prior to screening 3. Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings. 4. The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to quetiapine. 2. Current or relevant history of serious, severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I) except schizophrenia. 3. Presence of Postural Hypotension (Defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing up) 4. History of syncope or orthostatic hypotension 5. Any condition/ Abnormal baseline findings that in the investigator?s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study. 6. Patients with a known intolerance or lack of response to previous treatment with quetiapine. 7. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period. 8. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others. 9. Patients having Hypertension or on any antihypertensive medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmin,ss, Cmax,ss, AUCÏ?,ssTimepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| Ctrough, Tmax, t1/2, PTF, Css,av,λzTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Harshit Shah
Nil
Outcome results
None listed