SWitching to Abilify Trial (SWAT)
Phase 4
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00304616
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- 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, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs.
Aripiprazole (10\~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
- Secondary Outcome Measures
Name Time Method Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26 IAQ (at week 8) POM (at week 1, 2, 4, 8) GAF (at week 8 & end of study) CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26) AEs, Vital Signs, Weight gain, Prolactin increase, extrapyramidal syndrome, sleep disturbance, Laboratory tests (at week 1, 2, 4, 8 & every 4 weeks until week 26).
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of