SWitching to Abilify Trial (SWAT)
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|ClinicalTrials.gov Identifier: NCT00304616|
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : December 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||October 2007|
- CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304616
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Chang-Yoon Kim, Prof.||Asan Medical Center|