None listed
Conditions
Interventions
PNU-101387G Type of group
All enrolled patients will be dosed with PNU-101387G 10 mg during week 1 of the doseadjustment period. If no intolerance is observed at the end of week 1, the dose level is to be
escalated by 1 dose level to 20 mg for the second week. If intolerance occurs during or at the end of week 1, the dose level is to be reduced by 1 dose level to 5 mg for the second week. The same procedure is to be followed at the end of each of the 6 weeks of the doseadjustment period, ie, escalate by 1 dose level i
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Consentir para participar voluntariamente y firmar un Consentimiento informado por escrito antes de cualquier procedimiento de estudio en Screen o tener un consentimiento del representante legalmente aceptable y firmar si el paciente se considera incompetente para tomar una decision informada. • Si es mujer, debe ser posmenopausica o, si tiene potencial de maternidad, debe: o acuerda evitar el embarazo durante el estudio o tener una prueba de embarazo en suero negativa en la pantalla o utilice regularmente un metodo anticonceptivo aceptado (segun lo determine el investigador) como anticonceptivos orales, anticonceptivos implantables o inyectables, dispositivos intrauterinos, metodos de barrera, abstinencia o esterilizacion quirurgica • Debe haberse inscrito y haber recibido al menos 3 semanas de medicacion de estudio cegada en el protocolo 387GCNS0069-011. • Estar dispuesto y ser capaz de cumplir con el protocolo y seguir las instrucciones. • Tener 18 años de edad o mas. • Cumplir con los criterios del DSM-IV para la esquizofrenia (subtipos 295.10, 295.20, 295.30, 295.60 o 295.90).
Exclusion criteria
Exclusion criteria: •Experienced clinically serious or drug-related adverse events while participating in protocol 387GCNS0069-011. •History or evidence of clinically relevant disease or a medical history or physical examination with any abnormalities which would preclude participation. •Clinically significant abnormalities on the ECG or a QT interval of >440 milliseconds at baseline. •Abnormal laboratory values judged clinically significant. •A positive urine screen for cocaine/cocaine metabolites, amphetamines, barbiturates, or opiates (a second screening is allowed if the first one is positive and the patient does not have a history of DSM-IV drug dependency). •A positive pregnancy test or currently breastfeeding. •Require treatment with any drug that might interact adversely with or obscure the action of the study medication, including antiarrythmic agents and medications which are potent inhibitors of CYP3A4 (eg, nefazodone and azole antifüngals) and inducers of CYP3A4 (eg, carbamazepine, dexamethasone, rifampin, phenobarbital, phenytoin, sulfadimidine, sulfmpyrazone, and macrolide antibiotics). •A history of substance dependence (drug or alcohol: DSM-IV critcria) within the past three months (prior to enrollment in Protocol 387GCNS0069-011). •Patients deemed by the investigator to be unsafe for the trial, •Have previously been enrolled into this study, or are currently participating in any other drug or intervention study that requires treatment with an investigational medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Safety laboratories, electrocardiogram (ECG) monitoring, vital signs, Simpson Neurological Scale (to measure extrapyramidal side effects), Barnes Scale (to measure akathisia), and adverse events. Measure:Safety and Tolerability Timepoints:Simpson Neurological Scale and Barnes Scale, Physical Examination and ECG will be performed every week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions (CGI). Measure:Therapeutic Response Timepoints:PANSS, CGI-Severity, CGI-Change on every week ; Outcome name:The change from baseline in selected items of the Wisconsin Card Sort Test (WCST) and Califomia Verbal Leaming and Memory Test (CVLT) scores (at selected sites only). Measure:Effects on cognition Timepoints:CVLT and WCST every 2 weeks ; Outcome name:Study Terminatlon Report Measure:Dropout Rate Timepoints:On the final visit | — |
Outcome results
None listed