BA/BE study of Clozapine 100 mg tablets in Schizoprenia patients
- Conditions
- Health Condition 1: null- Schizoprenia
- Registration Number
- CTRI/2015/05/005824
- Lead Sponsor
- AurobindoPharmaLimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
1.Patients diagnosed with a) treatment-resistant schizophrenia or; b)
schizophrenia, chronic (all types) and in a residual phase or in remission,
or schizoaffective disorder according to Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition (DSM-IV) criteria.
2. Patients with Body mass index between 18 and 35kg/m2 and aged
between 18 and 60 years.
3. Patients who are appropriate candidates for Clozapine therapy (as stated
in product labeling) and have been taking a stable dose of Clozapine 100
mg twice daily for at least three months before enrolment in the study.
4. Patients who are healthy as determined by physical examination, medical
history, and no significant abnormality in any of the laboratory parameters
including ECG and Chest X-ray.
5. Ability to comprehend the full nature and purpose of the study, including
possible risks and adverse events; ability to co-operate with the
Investigator and to comply with the requirements of the entire study.
6. Patients/Legally Acceptable Representative has given written consent
after being advised of the nature and risks of the study.
7. Patients must have adequate hematologic reserve
i. Hemoglobin >=10gm/dL
ii. WBC (white blood cells) >4000 /mm3 or /μL
iii. Platelets >=100,000 mm3 or /μL
iv. ANC (absolute neutrophils count) >2000/mm3 or /μL
8. Adequate and stable hepatic function at screening as defined by:
i. Bilirubin <1.5 X ULN (upper limit of normal)
ii. AST/ ALT <1.5 X ULN
iii. Total Triglycerides <1.5 X ULN
iv. Total Cholesterol <1.5 X ULN
9. Adequate renal function at screening as defined by:
a. Creatinine <1.5 X ULN for the clinical laboratory
10.Female patients of childbearing potential must have a negative serum
pregnancy test at screening
1.History of suicidal tendencies (e.g. suicidal attempts) within the past 3
months prior to screening or immediate risk of harm to self or other at the
time of Screening, as judged by the investigator.
2. Absolute neutrophil count <= 2000 /mm3 or /μL and WBC count <= 4000
/mm3 or /μL.
3. Elderly patients with diagnosed dementia related psychosis.
4. Patients with medical or surgical condition that might interfere with the
absorption, metabolism, or excretion of Clozapine or other study
medications.
5. Patients with history of granulocytopenia or myeloproliferative disorder,
either drug-induced or idiopathic.
6. Patients with history of clinically significant cardiovascular, renal,
hepatic, respiratory, endocrine (except noninsulin-dependent diabetes
mellitus), or gastrointestinal disease.
7. Patientâ??s positive for HIV, HBs (Ag) or HCV.
8. Patients with history of epilepsy or seizures or are comatose or
experiencing severe central nervous system depression.
9. Patients are unable to communicate with the investigator.
10. Patients with history of allergic reactions to Clozapine or chemically
related psychotropic drugs.
11. Patients having concurrent primary psychiatric or neurological diagnosis,
including organic mental disorder (DSM-IV criteria), mental retardation,
severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.
12. Patients who had undergone electroconvulsive therapy within the past one
month.
13. Patients have demonstrated clinically significant homicidal behavior
within the past 12 months.
14. Patients have received an investigational drug within the past 90 days.
15. Patients having a history of narrow-angle glaucoma.
16. Patients requiring treatment with drugs that are known to interact with
Clozapine (e.g., agents having a well-known potential to suppress bonemarrow
functioning, drugs that are highly protein-bound, cimetidine, or
phenytoin). Clozapine may also potentiate the effects of antihypertensive
and anticholinergics; therefore, caution should be taken if patients
receiving these drugs are enrolled in the study.
17. Patients with known history of phenylketonuria.
18. Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm hg or more and / or a drop in diastolic blood pressure of 20 mm
Hg or more on standing)
19. Concurrent use of antihypertensive medication or any medication that
might pre-dispose to orthostatic hypotension.
20. Concurrent use of other drugs known to suppress bone marrow function.
21. Positive tests for drug or alcohol abuse at screening or baseline.
22. A history of alcohol or drug dependence by Diagnostic and statistical
manual of Mental Disorders IV (DSM-IV) criteria during the 6-month
period immediately prior to study entry.
23. History of multiple syncopal episodes.
24. Patients who smoke.
25. Expected changes in concomitant medication during the period of study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method