Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
Source: ClinicalTrials.gov NCT02360319 ↗Summary
Linked Publications (2)
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Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Hospitalization |
530.6; 613.7 | — |
| SECONDARY Total Number of Psychiatric Hospitalizations Per Treatment Arm |
208; 133 | — |
| SECONDARY Brief Psychotic Rating Scale (BPRS) Total Score |
35.59; 35.45; 30.7; 31.31; 30.73; 30.87 | — |
| SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores |
182.4; 177.7; 189.2; 178.2; 194.1; 180.8 | — |
| SECONDARY Quality of Life (QLS) Total Score |
63.60; 58.40; 68.45; 65.02; 62.21; 70.05 | — |
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT02360319) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.