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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician's Choice | Active Comparator | 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 |
|
| Aripiprazole Once Monthly | Experimental | Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any FDA approved antipsychotic agent | Drug | Investigators are free to choose the most appropriate treatment for their clients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Hospitalization | Assessments are done using best available data and patient interviews | Hospitalizations assessed every 2 months from baseline to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Psychiatric Hospitalizations Per Treatment Arm | Assessments are completed using best available data and patient interviews | Measured every 2 months from baseline to month 24 |
| Brief Psychotic Rating Scale (BPRS) Total Score |
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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
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
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| Name | Affiliation | Role |
|---|---|---|
| John M Kane, M.D. | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Frontera | Tucson | Arizona | 85713 | United States | ||
| San Fernando Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32667636 | Derived | Kane JM, Schooler NR, Marcy P, Correll CU, Achtyes ED, Gibbons RD, Robinson DG. Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Dec 1;77(12):1217-1224. doi: 10.1001/jamapsychiatry.2020.2076. | |
| 31050233 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2015 |
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| aripiprazole long acting injectable formulation | Drug |
|
The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms.
| Measured at Month 12 and Month 24 |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning | Measured at Month 12 and Month 24 |
| Quality of Life (QLS) Total Score | Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning. | Measured at Month 12 and Month 24 |
| Granada Hills |
| California |
| 91344 |
| United States |
| Stanford School of Medicine | Palo Alto | California | 94304 | United States |
| Henderson Behavioral Health | Fort Lauderdale | Florida | 33319 | United States |
| Meridian Behavioral Healthcare | Gainesville | Florida | 32614 | United States |
| U. of Florida College of Medicine | Jacksonville | Florida | 32209 | United States |
| LifeStream Behavioral Center | Leesburg | Florida | 34749 | United States |
| Suncoast Center | St. Petersburg | Florida | 33711 | United States |
| Apalachee Center, Inc. | Tallahassee | Florida | 32308 | United States |
| Jerome Golden Center for Behavioral Health | West Palm Beach | Florida | 33407 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Chestnut Health Systems | Granite City | Illinois | 62040 | United States |
| University of Iowa Psychiatry Research | Iowa City | Iowa | 52242 | United States |
| Corrigan Mental Health Center | Fall River | Massachusetts | 02720 | United States |
| U. Mass Medical School | Worcester | Massachusetts | 01605 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Early Treatment and Cognitive Health | East Lansing | Michigan | 48823 | United States |
| Cherry Street Health Services | Grand Rapids | Michigan | 49503 | United States |
| WMU School of Medicine | Kalamazoo | Michigan | 49048 | United States |
| Community Mental Health for Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| Muskegon County Community Mental Health | Muskegon | Michigan | 49433 | United States |
| Saint Louis University CRU | St Louis | Missouri | 63104 | United States |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03101 | United States |
| Healthy Perspectives | Nashua | New Hampshire | 03060 | United States |
| New Bridge Medical Center | Paramus | New Jersey | 07652 | United States |
| Carolina Behavioral Care | Durham | North Carolina | 27704 | United States |
| Central Community Health Board of Hamilton Co. | Cincinnati | Ohio | 45219 | United States |
| The Counseling Center of Wayne and Holmes Counties | Wooster | Ohio | 44691 | United States |
| PeaceHealth Medical Group | Eugene | Oregon | 97401 | United States |
| Carey Counseling Center | Huntingdon | Tennessee | 38344 | United States |
| Spindletop Center | Beaumont | Texas | 77701 | United States |
| Baylor College of Medicine | Houston | Texas | 77054 | United States |
| MHC Community Healthcore | Longview | Texas | 75601 | United States |
| The Center for Health Care Services | San Antonio | Texas | 78201 | United States |
| Psychiatric & Behavioral Solutions | Salt Lake City | Utah | 84105 | United States |
| Kane JM, Schooler NR, Marcy P, Achtyes ED, Correll CU, Robinson DG. Patients With Early-Phase Schizophrenia Will Accept Treatment With Sustained-Release Medication (Long-Acting Injectable Antipsychotics): Results From the Recruitment Phase of the PRELAPSE Trial. J Clin Psychiatry. 2019 Apr 23;80(3):18m12546. doi: 10.4088/JCP.18m12546. |
| FG001 | 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 aripiprazole long acting injectable formulation |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients |
| BG001 | 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 aripiprazole long acting injectable formulation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Hospitalization | Assessments are done using best available data and patient interviews | Intent to treat | Posted | Number | 95% Confidence Interval | days | Hospitalizations assessed every 2 months from baseline to Month 24 |
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| ||||||||||||||||||||||||||||
| Secondary | Total Number of Psychiatric Hospitalizations Per Treatment Arm | Assessments are completed using best available data and patient interviews | Intent to treat | Posted | Number | Hospitalizations | Measured every 2 months from baseline to month 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Brief Psychotic Rating Scale (BPRS) Total Score | The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms. | Posted | Mean | Standard Deviation | Scores on a scale | Measured at Month 12 and Month 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning | Posted | Mean | Standard Deviation | Scores on a scale | Measured at Month 12 and Month 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QLS) Total Score | Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning. | Intent to treat | Posted | Mean | Standard Deviation | Scores on a scale | Measured at Month 12 and Month 24 |
|
|
All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients | 2 | 255 | 104 | 255 | 161 | 241 |
| EG001 | 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 aripiprazole long acting injectable formulation | 0 | 234 | 68 | 234 | 169 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Psychiatric hospitalization/illness | Psychiatric disorders | Systematic Assessment | Worsening of psychosis or other psychiatric condition |
| |
| Jail | Social circumstances | Systematic Assessment |
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| Serious psychiatric event not requiring hospitalization | Psychiatric disorders | Systematic Assessment |
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| Confusion | General disorders | Systematic Assessment |
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| Cholecystectomy | Gastrointestinal disorders | Systematic Assessment |
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| Abcess | Infections and infestations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Angina | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lactation | Reproductive system and breast disorders | Systematic Assessment |
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| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Drug Overdose | Social circumstances | Systematic Assessment |
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| Chest laceration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight Gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Hyperprolactemia | Endocrine disorders | Systematic Assessment |
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| Elevated cholesterol levels | Cardiac disorders | Systematic Assessment |
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| Hepatic enzyme abnormalities | Hepatobiliary disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Somnolence | Psychiatric disorders | Systematic Assessment |
| ||
| Hostility/aggression | Psychiatric disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Restlessness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrica Marcy | Vanguard Research Group | 3474398035 | pmarcy@northwell.edu |
| Oct 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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