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SWitching to Abilify Trial (SWAT)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Aripiprazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Outcomes

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).

Full Information

First Posted
March 17, 2006
Last Updated
December 15, 2009
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00304616
Brief Title
SWitching to Abilify Trial (SWAT)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Aripiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone
Primary Outcome Measure Information:
Title
CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)
Secondary Outcome Measure Information:
Title
Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
Title
IAQ (at week 8)
Title
POM (at week 1, 2, 4, 8)
Title
GAF (at week 8 & end of study)
Title
CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Yoon Kim, Prof.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

SWitching to Abilify Trial (SWAT)

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