Schizophrenia
Conditions
Interventions
Trade Name: Abilify
Product Name: Abilify
Pharmaceutical Form: Tablet
INN or Proposed INN: Aripiprazole
Current Sponsor code: OPC-14597
Other descriptive name: BMS-337039
Concentration unit: mg milli
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria (Appendix 2 of the protocol) 2) Out-patients having symptoms which in the clinical judgment of the treating psychiatrist require treatment with antipsychotic (AP) medication. 3)Patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone. 4) Men and women, aged 18 - 65 years. 5) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. 6) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. 2) WOCBP using a prohibited contraceptive method. No specific contraceptive methods are prohibited in this study. Women practicing abstinence should use a reliable method of contraception (except birth control pills, See Section 5.1of the protocol) if they choose to become sexually active during the study. 3) Women who are pregnant or breastfeeding 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide; 6) Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes; 7) Patients who have met DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening; 8) Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments; 9) Patients with a history of neuroleptic malignant syndrome; 10) Patients with epilepsy, a history of seizures (except for a single childhood febrile seizure), a history of stroke or who have a history or evidence of other medical conditions that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial; 11) Patients who would be likely to require prohibited concomitant therapy during the trial (see Section 6.4 of the protocol); 12) Patients who have previously been treated with aripiprazole in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month. 13) Patients with detectable levels of cocaine, heroin or opioids in the drug screen. Patients with a positive drug screen for stimulants or other drugs of abuse are to be discussed with BMS and approval granted prior to treatment; 14) The following laboratory test results, vital sign and ECG findings are exclusionary: QTc > 450 msec Platelets 3x upper limit of normal Creatinine > 2 mg/dL Diastolic blood pressure > 105 mmHg 15) Patients who are known to be allergic or hypersensitive to aripiprazole or other dihydrocarbostyrils. 16) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) fortreatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone. The proportion of patients who discontinued because of AE’s will be compared between the 2 switching strategies.;Secondary Objective: To investigate whether out of two switching strategies one is best in term of: • Patient's and caregiver's preference of medicine (POM) • Subjective well-being under neuroleptics (SWN) • Extra-pyramidal signs and symptoms Simpson-Angus Scale (SAS). To examine the impact of switching from risperidone to aripiprazole in terms of effectiveness, efficacy, effect on cognitive functioning and on Outcomes Research measures and to further evaluate safety and tolerability of aripiprazole using: • Clinical Global Impression - Improvement (CGI-I) • Investigator’s Assessment Questionnaire (IAQ) • Positive and Negative Syndrome Scale (PANSS) • GEOPTE Social Cognition scale • Impact of Weight on Quality of Life (IWQoL ) • Sexual functioning using the Arizona Sexual Experience Scale (ASEX) • Other safety and tolerability measures including prolactin levels and weight;Primary end point(s): Proportion of patients who discontinue due to AE’s. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed