- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203056
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (APPRAISE)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Is between 18 and 45 years of age, inclusive, at Screening.
- Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type.
- Has a first episode of a psychotic illness that occurred within the 24 months before entry.
- Fluency (oral and written) in the English language.
- Exhibits tolerability to ARI ORAL during the Stabilization period.
- Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located.
- Agrees to abide by the contraceptive requirements of the protocol.
- Additional criteria may apply
Exclusion Criteria:
- Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury.
- Premorbid IQ less than 70.
- Is currently pregnant or breastfeeding, or is planning to become pregnant during the study.
- Is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole.
- History of poor or inadequate response to an adequate trial of oral or injectable aripiprazole.
- Has received AL-LAI or IM depot aripiprazole within two months prior to Randomization.
- Has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm.
- Is currently being treated with clozapine.
- Has participated in a clinical drug trial involving any drug within the past two months.
- Has a current DSM-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening SCID.
- Patient is an imminent danger to himself/herself.
- History of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia.
- Additional criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ARI-ORAL: Aripiprazole Oral Antipsychotic
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.
|
oral aripiprazole
Other Names:
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Experimental: AL-LAI: Long-Acting Injectable Antipsychotic
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.
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Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
Other Names:
12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exacerbation or Relapse of Psychotic Symptoms
Time Frame: 12 months
|
Number of participants who experienced an exacerbation and/or relapse following a period of absence or relative low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale
|
12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
Time Frame: mean change from baseline to the 12 month point
|
The groups will be compared on change in this measure of role functioning.
Scores range from 1 to 10, with higher indicating better role functioning.
Change scores can theoretically range from 0 to 9
|
mean change from baseline to the 12 month point
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Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
Time Frame: 12 months
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The change from Baseline to One-year on the MATRICS Consensus Cognitive Battery Overall Composite score. MATRICS is the abbreviation for Measurement and Treatment Research to Improve Cognition in Schizophrenia. T scores do not have an absolute minimum or maximum. Higher scores represent better cognition. The sex and age adjusted T-score was used. The T-Score has a population mean of 50 and standard deviation of 10. Fewer subjects analyzed than enrolled because only 9 subjects reached the 12 month point by study discontinuation and had MCCB data. |
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kenneth L Subotnik, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Depression
- Depressive Disorder
- Schizophrenia
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
- Aripiprazole lauroxil
Other Study ID Numbers
- PATS 20184225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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