Status:
COMPLETED
24-Hour Time Course of Striatal Dopamine D2 Receptor Occupancy of Ziprasidone: A PET Study
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Pfizer
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Ziprasidone is recommended to be dosed twice daily for the treatment of schizophrenia, based on peripheral pharmacokinetics and a knowledge of its half life in plasma level (5-10 hours). However, the ...
Detailed Description
PET studies have demonstrated a therapeutic window of dopamine D2 receptor occupancy (60-80%) in patients with schizophrenia. This observation has been used to predict the therapeutic dose range. Zipr...
Eligibility Criteria
Inclusion
- Age of 18 - 60 years.
- DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic disorder NOS
- In- or outpatients
- Physician-of-record's agreement to switch a previous antipsychotic to ziprasidone due to concern about tolerability/ineffectiveness/potential side effects of the previous drug when prescribed
Exclusion
- Incapacity to provide consent to psychiatric treatment
- Participation in this study would result in exceeding the annual radiation dose limits (20 mSv) for human subjects participating in research studies.
- Substance abuse or dependence (within past six months)
- Positive urine drug screen
- Positive serum pregnancy test at screening or positive urine pregnancy test before PET scan
- History of clinically significant physical illness or risk factors for drug-induced arrhythmias secondary to QT/QTc interval prolongation
- Presence of risk factors for significant electrolyte disturbances, including diuretic therapy, protracted diarrhea/vomiting, water intoxication, eating disorder, and alcoholism
- A known history of QT prolongation (including congenital long QT syndrome), recent acute myocardial infarction or uncompensated heart failure
- Clinically significant ECG abnormality at screening including a QT/QTc of 450 msec and greater
- Being treated with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, methadone, or clozapine
- A previous history of intolerance or hypersensitivity to ziprasidone or lactose
- History of treatment with long-acting (depot) neuroleptic antipsychotic medication within 6 months
- Subjects at immediate risk of committing harm to self or others
- Metal implants or a pace-maker that would preclude the MRI scan
- History of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention
- Unstable physical illness or significant neurological disorder including a seizure disorder
- Size of head, neck, and body being unable to fit PET and MRI scanners
- Refusal to give consent to investigator to communicate with physician of record for the entire duration of the study
- Psychiatric concerns raised by the physician-of-record regarding participation in the study
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00818298
Start Date
January 1 2009
End Date
June 1 2011
Last Update
July 9 2012
Active Locations (1)
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1
Centre for Addiction and Mental Health - PET Centre
Toronto, Ontario, Canada, M5T 1R8