SWitching to Abilify Trial (SWAT)

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00304616

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone	Phase 4

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).

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.