Ziprasidone outcome and tolerability: a practical clinical trial with plasma drug levels.
BACKGROUND
The aim of this study was to evaluate clinical outcomes and the tolerability of ziprasidone in relation to its plasma levels.


METHODS
Thirteen inpatients affected by schizophrenia were included in the study after an acute exacerbation phase. Ziprasidone monotherapy was administered for a period of eight weeks at a mean dose of 123.07+/-30.38 mg/day. Plasma concentrations were measured by high-performance liquid chromatography.


RESULTS
Nine patients completed the study. A significant clinical improvement was observed, especially in negative symptoms ( P<0.05), and there was a significant improvement in extrapyramidal symptoms ( P<0.01). Clinical laboratory tests, such as ECG and weight, did not significantly change from baseline. Plasma ziprasidone levels ranged from 20 ng/mL to 160 ng/mL (mean: 75.8 ng/mL) and were significantly related to the improvement in negative symptoms.


CONCLUSIONS
The study showed that ziprasidone was effective and tolerable, that use of ziprasidone was characterized by an absence of extrapyramidal symptoms and weight gain, and that no alterations in clinical laboratory tests occurred. The findings suggest a relationship between plasma levels and the clinical response to negative symptoms of schizophrenia.
Mauri
M C
MC
Clinical Neuropsychopharmacology Unit, Department of Internal Medicine, Clinical Psychiatry, University of Milan, Fondazione IRCCS Ospedale Maggiore Policlinico, Via F. Sforza 35, Milano, Italy. maurimc@policlinico.mi.it
Colasanti
A
A
Rossattini
M
M
Volonteri
L S
LS
Dragogna
F
F
Fiorentini
A
A
Fiorentini
A
A
Valli
A
A
Papa
P
P
D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001835:Body Weight; D002851:Chromatography, High Pressure Liquid; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D013844:Thiazoles / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone