None listed
Conditions
Interventions
Group 1 Type of group
PNU-101387G 1.5 mg PO daily for 6 weeks
Group name:Group 5 Type of group
Placebo orally daily for 6 weeks.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Consent to participate voluntarily and sign a Written Informed Consent prior to any study procedure at the time of filtering or have the consent of a legally acceptable representative and sign if the patient is considered incompetent to make an informed decision; •Male or female. If you are a woman, you must be post-menopausal, or if you have the potential To become pregnant, you must: Agree to avoid pregnancy during the study; have a negative serum test at the time of filtering; regularly use an accepted method of birth control (as determined by the investigator) such as oral contraceptive, implantable or injectable contraceptive, an intrauterine device, barrier methods, or be surgically sterilized. • Be willing and able to remain hospitalized throughout the protocol (4 weeks minimum, 7 weeks maximum); • Be willing and able to comply with the protocol and follow instructions; • Be between 18 and 65 years of age, inclusive; • Comply with the DSM-IV criteria for schizophrenia (subtypes 295.10, 295.20, 295.30, 295.50 or 295.90) • Either be untreated at this time and be presenting in an acute manner or • Have a score of 60 or higher on the Positive and Negative Symptom Scale (ANSS) at the time of randomization; • Have a responsible person to ensure compliance with the treatment during the participation as a possible external patient.
Exclusion criteria
Exclusion criteria: • History of failure to respond to standard antipsychotic treatments after an adequate period of treatment and with a therapeutic dose; • History or evidence of a disease with clinical relevance or a medical history or physical examination with any abnormalities that could prevent participation. • Abnormalities with clinical significance in the electrocardiogram or a QTc interval of> 440 milliseconds; • Abnormal laboratory values ​​judged clinically; • A history of substance dependence (drug or alcohol, DSM-IV criteria) during the past three months or a positive urine screening test for cocaine / cocaine metabolites, amphetamines, barbiturates, or opiates (a second filter is allowed if the first is positive and the patient does not have a history of DSM-IV dependence); • A positive pregnancy test or you are currently breastfeeding; • Require treatment with any drug that may adversely interact with, or obscure the action of, study medications, including antiarrhythmic agents and drugs that are potent CYP3A4 inhibitors (eg, antifungal agents, nefazodone and azole), CYP3A4 inducers, such as ( carbamazepine, dexamethasone, rifampin, phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone and macrolide antibiotics) inducers of CYP1A2 (eg, omeprazole, rifampin) and CYP1A2 inhibitors (fluvoxamine); • Have received oral neuroleptics within 7 days of randomization or neuroleptic deposition during a cycle (haloperidol - minimum of three weeks, prolixin a minimum of two weeks) prior to randomization; at the discretion of the investigators, the drug-free period for oral neuroleptics can be reduced to 3 days prior to randomization if the patient´s clinical condition so requires; • Have received continuous treatment with a benzodiazepine or any treatment with an antidepressant, lithium, carbamazepine, or valproic acid within 1 week of randomization (or for four weeks if treated with fluoxetine or MAOI); • Patients considered by the researcher as insecure for the study; • Have been previously randomized within this study, or are currently participating in any other medication or intervention study that requires treatment with any investigational medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Positive and Negative Syndrome Scale (PANSS) Brief Psychiatric Rating Scale (BPRS) Clinical Global Impressions (COI) Calgary Depression Scale California Verbal Learning Test (CVLT) Measure:Efficacy Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Vital signs Psychiatric History Concomitant psychotropic medications Neurological Rating Scale (Simpson Angus Scale) Bames Acatisia Scale Electrocardiogram Measure:Clinical Safety Timepoints:During the study ; Outcome name:Drug Concentration Measures Measure:Pharmacokinetics Timepoints:Blood samples will be taken to determine the concentrations of PNU-101387 immediately prior to the first dose on day 1, and also at least 2 hours after the dose on Days 7, 14, 21, 28, 35, and 42. | — |
Outcome results
None listed