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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304616
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : December 17, 2009
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
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 : October 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. CGI-I mean score(at week 1, 3, 4, 8 & every 4 weeks until week 26)

Secondary Outcome Measures :
  1. Changes in PANSS total & PANSS subscore & depression subscore originated from PANSS (at week 4, 8 & every 4 weeks until week 26
  2. IAQ (at week 8)
  3. POM (at week 1, 2, 4, 8)
  4. GAF (at week 8 & end of study)
  5. CGI-S (at week 1, 3, 4, 8 & every 4 weeks until week 26)
  6. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00304616

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
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Principal Investigator: Chang-Yoon Kim, Prof. Asan Medical Center

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Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd. Identifier: NCT00304616     History of Changes
Other Study ID Numbers: KOP-010402
First Posted: March 20, 2006    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009
Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors