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Atypical Antipsychotic
Aripiprazole Lauroxil for Schizoaffective Disorder (APPRAISE Trial)
Phase 4
Waitlist Available
Led By Kenneth L Subotnik, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
APPRAISE Trial Summary
This trial will compare the effectiveness of two forms of aripiprazole in preventing the return of psychotic symptoms in patients who have recently developed schizophrenia.
Eligible Conditions
- Schizoaffective Disorder
- Schizophreniform Disorder
- Schizophrenia
APPRAISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exacerbation or Relapse of Psychotic Symptoms
Secondary outcome measures
Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
Side effects data
From 2017 Phase 4 trial • 51 Patients • NCT026343206%
Anxiety
4%
Suicidal ideation
4%
Psychotic disorder
2%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aripiprazole Lauroxil
APPRAISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AL-LAI: Long-Acting Injectable AntipsychoticExperimental Treatment2 Interventions
Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: For patients assigned to the AL-LAI (aripiprazole lauroxil- long-acting injections), initiation of AL-LAI will begin with a one-day initiation regimen (using AL-NCD IM (aripiprazole lauroxil NanoCrystal Dispersion)). Subsequent dosing of AL-LAI will be flexible based on clinician judgment. Treatment with AL-LAI can be initiated at a dose of 441mg or 661mg (administered monthly), 882mg (administered monthly or every 6 weeks), or 1064mg (administered every 2 months). Note: These dosages are not assigned levels of the intervention and dosage levels may be changed at any time throughout the 12-month intervention based on clinical need and clinician judgement. Starting dosages do not indicate separate treatment conditions.
Group II: ARI-ORAL: Aripiprazole Oral AntipsychoticActive Control1 Intervention
Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: Patients assigned to the oral medication condition will continue with ARI-ORAL. ARI-ORAL dosage will be flexible and dosage will be at the discretion of the treating psychiatrist. Patients discontinuing ARI-ORAL study drug after Randomization to oral antipsychotic medication, can remain in active treatment and follow-up within the study, and may be prescribed any of a number of first-line oral antipsychotics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aripiprazole lauroxil
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,836 Total Patients Enrolled
Alkermes, Inc.Industry Sponsor
114 Previous Clinical Trials
26,801 Total Patients Enrolled
Kenneth L Subotnik, PhDPrincipal InvestigatorUniversity of California, Los Angeles
Frequently Asked Questions
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