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 |
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Recruitment Status :
Completed
First Posted : February 10, 2015
Results First Posted : November 17, 2020
Last Update Posted : December 2, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Any FDA approved antipsychotic agent Drug: aripiprazole long acting injectable formulation | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 489 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Any FDA approved antipsychotic agent
Investigators are free to choose the most appropriate treatment for their clients |
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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
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Drug: aripiprazole long acting injectable formulation |
- 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
- Total Number of Psychiatric Hospitalizations Per Treatment Arm [ Time Frame: Measured every 2 months from baseline to month 24 ]Assessments are completed using best available data and patient interviews
- Brief Psychotic Rating Scale (BPRS) Total Score [ Time Frame: Measured at Month 12 and Month 24 ]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.
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores [ Time Frame: Measured at Month 12 and Month 24 ]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
- Quality of Life (QLS) Total Score [ Time Frame: Measured at Month 12 and Month 24 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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
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
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
| Principal Investigator: | John M Kane, M.D. | Northwell Health |
Documents provided by Vanguard Research Group:
| Responsible Party: | Vanguard Research Group |
| ClinicalTrials.gov Identifier: | NCT02360319 |
| Other Study ID Numbers: |
COL.AOM.2013.005 |
| First Posted: | February 10, 2015 Key Record Dates |
| Results First Posted: | November 17, 2020 |
| Last Update Posted: | December 2, 2020 |
| Last Verified: | October 2020 |
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First episode or recent onset |
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Aripiprazole Antipsychotic Agents Antidepressive Agents Psychotropic Drugs Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs 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 |