A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment with Aripiprazole in Schizophrenic Out-patients who areExperiencing Insufficient Efficacy with Risperidone and/or Safety and Tolerability Issues, While on Risperidone. Protocol version 1.0 dated 2005-03-31, andPharmacogenetics Blood Sample Amendment 01, version 1.0 dated 2005-04-11
- Conditions
- Schizophrenia
- Registration Number
- EUCTR2005-000472-40-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
1) Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR 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
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 < 75,000/mm3
Hemoglobin < 9g/dL
Neutrophils < 1000 cells/mcgL (or equivalent)
AST (SGOT) or ALT (SGPT) > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method