Schizophrenia
Conditions
Interventions
Trade Name: Abilify
Product Name: Abilify
Pharmaceutical Form: Tablet
INN or Proposed INN: Aripiprazole
Current Sponsor code: OPC-14597
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must be competent to understand the nature of the study, sign the informed consent, agree to comply with prescribed dosage regimens, report for regularly scheduled visits with their caring physician, able to provide reliable information for safety, efficacy and Quality of life assessments and communicate to the psychiatrist about adverse events and concomitant medication use; - The informed consent process must be documented by signing the informed consent form prior to any study-related procedures including alteration in medications in preparation for study entry; - Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria; - Patients with a score of 2 to 6 in the CGI-S scale at baseline; - Either ambulatory or hospitalized patients having symptoms which in the clinical judgment of the treating psychiatrist require treatment with antipsychotic medication (AP); this includes: patients in whom an AP is started and patients who, stabilized or not stabilized, in the clinical judgment of the treating psychiatrist, require a change of their current AP treatment; because of lack of efficacy or because of occurrence of side effects; - Men and women, aged of minimum 18; - 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; - WOCBP must have a negative serum or urine pregnancy test 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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; - WOCBP using a prohibited contraceptive method; - Women who are pregnant or breastfeeding; - Women with a positive pregnancy test on enrollment or prior to study drug administration; - Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes; - Patients with a score of 0 (not assessed) -1 (normal, not at all ill) or 7 (amongst the most extremely ill patients) in the CGI-S scale at baseline; - Patients who have met DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening; - Treatment with a long-acting antipsychotic in which the last dose was within 3 weeks of randomization; - Patients with a history of neuroleptic malignant syndrome; - 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; - Patients who would be likely to require prohibited concomitant therapy during the trial; - Patients who have participated in any clinical trial with an investigational agent within the past month; - Patients who are known to be allergic or hypersensitive to aripiprazole or other dihydrocarbostyrils; - Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of a 12-week treatment with aripiprazole in a broad range of schizophrenic patients. The overall effectiveness will be evaluated by the CGI-I at Week 12. ;Secondary Objective: 1) To correlate evaluation of treatment effectiveness by: - Physicians: CGI-S scale, CGI Therapeutic Index scale, IAQ questionnaire - Patients: PGI-I scale, QLESQ questionnaire, POM questionnaire - Care givers and/or family: PGI-I scale and POM questionnaire 2) To evaluate cognitive function by California Verbal Learning Test and Verbal Fluency. 3) To evaluate compliance by drug accountability records and by Drug Attitude Inventory (DAI) questionnaire. 4) To evaluate safety and tolerability by the incidence and severity of adverse events, serious adverse events, discontinuation from study due to adverse events and weight changes. ;Primary end point(s): CGI – Improvement (CGI-I) scale at week 12 | — |
Countries
Belgium
Outcome results
None listed