SWitching to Abilify Trial (SWAT)

NCT00304616 | Completed Phase 4

• 1 other identifier: KOP-010402
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)

Secondary Outcomes (6)

• 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)

Interventions

Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; Amisulpride; Olanzapine; Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzodiazepines; Benzazepines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Pyrimidinones; Pyrimidines

Study Officials

• Chang-Yoon Kim, Prof.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 20, 2006
• Study Start: October 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: October 1, 2007
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

KR (1)