SchizophreniaPhase 4PRELAPSENCT02360319
Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
A Phase 4 study testing Any FDA approved antipsychotic agent and aripiprazole long acting injectable formulation in people with Schizophrenia, run by Vanguard Research Group at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Any FDA approved antipsychotic agent and aripiprazole long acting injectable formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 39 sitesUnited States
- Study dates
- 11 Dec 2014to 31 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
University of Michigan
Ann Arbor, Michigan, 48109
Grady Memorial Hospital
Atlanta, Georgia, 30303
Augusta University
Augusta, Georgia, 30912
Spindletop Center
Beaumont, Texas, 77701
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Central Community Health Board of Hamilton Co.
Cincinnati, Ohio, 45219
Carolina Behavioral Care
Durham, North Carolina, 27704
Early Treatment and Cognitive Health
East Lansing, Michigan, 48823
PeaceHealth Medical Group
Eugene, Oregon, 97401
Corrigan Mental Health Center
Fall River, Massachusetts, 02720
Henderson Behavioral Health
Fort Lauderdale, Florida, 33319
Meridian Behavioral Healthcare
Gainesville, Florida, 32614
San Fernando Mental Health Center
Granada Hills, California, 91344
Cherry Street Health Services
Grand Rapids, Michigan, 49503
Chestnut Health Systems
Granite City, Illinois, 62040
Baylor College of Medicine
Houston, Texas, 77054
Carey Counseling Center
Huntingdon, Tennessee, 38344
University of Iowa Psychiatry Research
Iowa City, Iowa, 52242
U. of Florida College of Medicine
Jacksonville, Florida, 32209
WMU School of Medicine
Kalamazoo, Michigan, 49048
LifeStream Behavioral Center
Leesburg, Florida, 34749
MHC Community Healthcore
Longview, Texas, 75601
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101
Community Mental Health for Central Michigan
Mount Pleasant, Michigan, 48858
Muskegon County Community Mental Health
Muskegon, Michigan, 49433
Healthy Perspectives
Nashua, New Hampshire, 03060
Creighton University
Omaha, Nebraska, 68131
Stanford School of Medicine
Palo Alto, California, 94304
New Bridge Medical Center
Paramus, New Jersey, 07652
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105
The Center for Health Care Services
San Antonio, Texas, 78201
Saint Louis University CRU
St Louis, Missouri, 63104
PsychCare Consultants Research
St Louis, Missouri, 63128
Suncoast Center
St. Petersburg, Florida, 33711
Apalachee Center, Inc.
Tallahassee, Florida, 32308
La Frontera
Tucson, Arizona, 85713
Jerome Golden Center for Behavioral Health
West Palm Beach, Florida, 33407
The Counseling Center of Wayne and Holmes Counties
Wooster, Ohio, 44691
U. Mass Medical School
Worcester, Massachusetts, 01605
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Any FDA approved antipsychotic agent, aripiprazole long acting injectable formulation
- Keywords
- First episode or recent onset
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any FDA approved antipsychotic agentDrug
Investigators are free to choose the most appropriate treatment for their clients
aripiprazole long acting injectable formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Any FDA approved antipsychotic agent |
| 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 Receives: Drug: aripiprazole long acting injectable formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Hospitalization
Assessments are done using best available data and patient interviews
Measured: Hospitalizations assessed every 2 months from baseline to Month 24
Secondary outcomes (4)
Total Number of Psychiatric Hospitalizations Per Treatment Arm
Assessments are completed using best available data and patient interviews
Measured: Measured every 2 months from baseline to month 24
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.
Measured: 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: 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: Measured at Month 12 and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start11 Dec 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanguard Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- John M Kane, M.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360319
- Sponsor's protocol ID
- COL.AOM.2013.005
- Acronym
- PRELAPSE
- Status last verified
- Oct 2020
- First submitted
- 2 Feb 2015
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32667636Kane 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.
PubMed 31050233
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02360319
- Acronym / sponsor ID
- PRELAPSE / COL.AOM.2013.005
- Conditions
- Schizophrenia
- Keywords
- First episode or recent onset
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Vanguard Research GroupUniversity, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician's Choice | Active comparator | Drug: Any FDA approved antipsychotic agentPrescribers 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 | Drug: aripiprazole long acting injectable formulationAripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
- First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any FDA approved antipsychotic agentInvestigators are free to choose the most appropriate treatment for their clients | Drug | Clinician's Choice |
| aripiprazole long acting injectable formulation | Drug | Aripiprazole Once Monthly |
Primary outcome
Time to First Hospitalization
Time frame: Hospitalizations assessed every 2 months from baseline to Month 24
Assessments are done using best available data and patient interviews
4 secondary outcomes
Total Number of Psychiatric Hospitalizations Per Treatment Arm
Time frame: Measured every 2 months from baseline to month 24
Brief Psychotic Rating Scale (BPRS) Total Score
Time frame: Measured at Month 12 and Month 24
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores
Time frame: Measured at Month 12 and Month 24
Quality of Life (QLS) Total Score
Time frame: Measured at Month 12 and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32667636Kane 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.
- Derived from this study: PubMed 31050233Kane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Kane, M.D. principal investigator
Northwell Health
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Any FDA approved antipsychotic agent and aripiprazole long acting injectable formulation in people with Schizophrenia, run by Vanguard Research Group at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Hospitalization (time frame: Hospitalizations assessed every 2 months from baseline to Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360319, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.