SWitching to Abilify Trial (SWAT)
This study has been completed.
Sponsor:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00304616
First received: March 17, 2006
Last updated: December 15, 2009
Last verified: December 2009
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Purpose
To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
Quetiapine
Quetiapine fumarate
Aripiprazole
Olanzapine
Olanzapine pamoate
U.S. FDA Resources
Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Primary Outcome Measures:
- CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
Secondary Outcome Measures:
- 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).
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2004 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304616
Locations
| Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
| Principal Investigator: | Chang-Yoon Kim, Prof. | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Korea Otsuka Pharmaceutical Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT00304616 History of Changes |
| Other Study ID Numbers: | KOP-010402 |
| Study First Received: | March 17, 2006 |
| Last Updated: | December 15, 2009 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
|
Schizophrenia Aripiprazole |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Quetiapine Olanzapine Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013