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Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics (PRELAPSE)

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ClinicalTrials.gov Identifier: NCT02360319
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Vanguard Research Group

Brief Summary:
The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode (<1 year of anti-psychotic medication) or early phase (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable (LAI) antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites (not individual patients) will be randomly assigned to either medication prescribed by their treating physician (with no restrictions) or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Any FDA approved antipsychotic agent Drug: aripiprazole long acting injectable formulation Phase 4

Detailed Description:

Approximately 40 U.S. sites will participate in the study in order to enroll approximately 500 patients over a year period. They will be recruited into two cohorts - the first episode cohort and the early phase (EP) cohort, with approximately 250 patients in each cohort. Enrollment of patients will be discontinued when the appropriate number for the target for each cohort is reached.

After providing written informed consent, patients will be screened for general eligibility by the clinical team at the site. Basic demographic data will be collected to determine suitability for inclusion into the study. The site will complete an information interview comprising data regarding symptomology and history, but the diagnosis of schizophrenia will fall to a centralized, remote blinded rater to enable consistency for eligibility.

Prescribers at sites in the clinician's choice arm can treat the patients in the manner most appropriate for that individual. Prescribers at sites in the Aripiprazole Once Monthly arm monthly will prescribe and administer the medication according to recommendations contained in the product labeling.

For a period of 2 years all subjects will receive bimonthly calls inquiring about visits to emergency rooms and hospitalization. At 4 month intervals information on use of services, insurance status, work, school attendance, and other service use outcomes will be assessed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment With Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia
Actual Study Start Date : December 11, 2014
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Clinician's Choice
Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years
Drug: Any FDA approved antipsychotic agent
Investigators are free to choose the most appropriate treatment for their clients

Experimental: Aripiprazole Once Monthly
Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years
Drug: aripiprazole long acting injectable formulation



Primary Outcome Measures :
  1. Time to first hospitalization [ Time Frame: Measured at 2 months ]
    Assessments are done using best available data and patient interviews

  2. Time to first hospitalization [ Time Frame: Measured at 4 months ]
    Assessments are done using best available data and patient interviews

  3. Time to first hospitalization [ Time Frame: Measured at 6 months ]
    Assessments are done using best available data and patient interviews

  4. Time to first hospitalization [ Time Frame: Measured at 8 months ]
    Assessments are done using best available data and patient interviews

  5. Time to first hospitalization [ Time Frame: Measured at 10 months ]
    Assessments are done using best available data and patient interviews

  6. Time to first hospitalization [ Time Frame: Measured at 12 months ]
    Assessments are done using best available data and patient interviews

  7. Time to first hospitalization [ Time Frame: Measured at 14 months ]
    Assessments are done using best available data and patient interviews

  8. Time to first hospitalization [ Time Frame: Measured at 16 months ]
    Assessments are done using best available data and patient interviews

  9. Time to first hospitalization [ Time Frame: Measured at 18 months ]
    Assessments are done using best available data and patient interviews

  10. Time to first hospitalization [ Time Frame: Measured at 20 months ]
    Assessments are done using best available data and patient interviews

  11. Time to first hospitalization [ Time Frame: Measured at 22 months ]
    Assessments are done using best available data and patient interviews

  12. Time to first hospitalization [ Time Frame: Measured at 24 months ]
    Assessments are done using best available data and patient interviews


Secondary Outcome Measures :
  1. Total number of days of psychiatric hospitalization calculated for each subject [ Time Frame: Measured every 2 months until Month 24 ]
    Assessments are done using best available data and patient interviews

  2. Change from baseline in BPRS [ Time Frame: Measured at Month 12 and Month 24 ]
    Remote rater performs assessments using verified scales

  3. Change from baseline in Clinical Global Impression Severity (CGI-S) [ Time Frame: Measured at Month 12 and Month 24 ]
    Remote rater performs assessments using verified scales

  4. Cost of care from data entered into Service Utilization and Resource Form [ Time Frame: Measured every 4 months until Month 24 ]
    Assessments are done using best available data and patient interviews

  5. Change from baseline in neuropsychological function (RBANS) [ Time Frame: Measured at Month 12 and Month 24 ]
    Remote rater performs assessments using a verified scale

  6. Change from baseline in quality of life (QLS) [ Time Frame: Measured at Month 12 and Month 24 ]
    Remote rater performs assessments using a verified scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Are able to provide written informed consent Have a confirmed diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM) 5 criteria using the SCID (Structured Clinical Interview for DSM disorders) Are between the ages of 18 and 35, inclusive Have the following history with antipsychotic medications

  1. First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis
  2. EP subjects: between 1 year and 5 years of lifetime exposure to antipsychotic medication or subjects with < 1 year of lifetime antipsychotic medication and more than one episode of psychosis.

For LAI subjects: Must be willing to accept an injectable form of treatment

Exclusion Criteria:

Have a current primary DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, and amnestic or other cognitive disorders.

For LAI sites only - have a known allergy or intolerance to aripiprazole, or a past negative response to aripiprazole that is not explained by nonadherence Be pregnant or lactating Have any unstable medical condition that, in the opinion of the investigator, would be detrimental to the subject or would confound the results of the study Subjects in the MRI subset only- presence of any metal implants, pacemakers, irremovable prosthetic devices, or other devices or situations that may preclude imaging


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 ClinicalTrials.gov identifier (NCT number): NCT02360319


  Show 39 Study Locations
Sponsors and Collaborators
Vanguard Research Group
Otsuka America Pharmaceutical
Investigators
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Principal Investigator: John M Kane, M.D. Northwell Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vanguard Research Group
ClinicalTrials.gov Identifier: NCT02360319     History of Changes
Other Study ID Numbers: COL.AOM.2013.005
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Vanguard Research Group:
First episode or recent onset
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists