Status:
COMPLETED
SWitching to Abilify Trial (SWAT)
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration
Detailed Description
This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, ...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Men and women, ages 18 to 65. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
- Patients who have not been hospitalized during last three months
- Patients who have kept clinically stable dosage during last one month
- Patients with a diagnosis of schizophrenia and schizoaffective disorder as defined by DSM-IV criteria
- Patients whose symptoms are not optimally controlled or whose antipsychotic medication is not well-tolerated, which in the clinical judgment of the treating psychiatrist require a change of treatment.
- Patients who have received antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine.
Exclusion
- Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Women who are pregnant or breastfeeding
- Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide
- Patients with a diagnosis of bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- Patients who have met DSM-IV criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
- 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
- Treatment with a long-acting antipsychotic (i.e., haloperidol decanoate or fluphenazine decanoate) 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), or a history of an abnormal EEG, severe head trauma, or stroke or who have a history or evidence of other medical conditions (e.g., congestive heart failure) 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 previously enrolled in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month
- Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00304616
Start Date
October 1 2004
End Date
October 1 2007
Last Update
December 17 2009
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736