SchizophreniaPhase 4APPRAISENCT04203056
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
A Phase 4 study testing Aripiprazole Lauroxil, ARI-ORAL and AL-NCD in people with Schizophrenia and Schizoaffective Disorder, Depressive Type, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Depressive Type, Schizophreniform Disorder
- What is being tested?
- Aripiprazole Lauroxil, ARI-ORAL and AL-NCD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 1 Oct 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.
Read the detailed description
This is a single-site 12-month open-label randomized study comparing the efficacy of the FDA-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. All assessments and treatment will take place at the UCLA Aftercare Research Program (300 UCLA Medical Plaza, Los Angeles, CA 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. The primary goal is to evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. All patients on oral medications will, at least initially, be treated with oral aripiprazole.
- Being tested
- Aripiprazole Lauroxil, ARI-ORAL, AL-NCD
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole LauroxilDrug
Also called Aristada
12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through
ARI-ORALDrug
Also called aripiprazole, Abilify
oral aripiprazole
AL-NCDDrug
Also called Aristada Initio
Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
| Study group | Role | What they receive |
|---|---|---|
| AL-LAI: Long-Acting Injectable Antipsychotic | Experimental | 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. Receives: Drug: Aripiprazole Lauroxil; Drug: AL-NCD |
| ARI-ORAL: Aripiprazole Oral Antipsychotic | Active comparator | 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. Receives: Drug: ARI-ORAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation or Relapse of Psychotic Symptoms
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
Measured: 12 months
Secondary outcomes (2)
Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
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
Measured: mean change from baseline to the 12 month point
Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start16 Dec 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Withdraw of financial support by industry collaborator
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.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial; 12-month longitudinal follow-through study (anticipate enrolling at least 128 patients of whom 90 will be randomized to one of the two arms)
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc.
- Responsible party
- Principal investigator, Kenneth L. Subotnik, PhD, University of California, Los Angeles
- Investigators
- Kenneth L Subotnik, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203056
- Sponsor's protocol ID
- PATS 20184225
- Acronym
- APPRAISE
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2019
- Last updated
- 28 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
- ClinicalTrials.gov ID
- NCT04203056
- Acronym / sponsor ID
- APPRAISE / PATS 20184225
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdraw of financial support by industry collaborator
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Alkermes, Inc.
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.
Detailed description
This is a single-site 12-month open-label randomized study comparing the efficacy of the FDA-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. All assessments and treatment will take place at the UCLA Aftercare Research Program (300 UCLA Medical Plaza, Los Angeles, CA 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. The primary goal is to evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. All patients on oral medications will, at least initially, be treated with oral aripiprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial; 12-month longitudinal follow-through study (anticipate enrolling at least 128 patients of whom 90 will be randomized to one of the two arms)
| Arm | Type | Receives |
|---|---|---|
| AL-LAI: Long-Acting Injectable Antipsychotic | Experimental | Drug: Aripiprazole Lauroxil, Drug: AL-NCDPatients 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. |
| ARI-ORAL: Aripiprazole Oral Antipsychotic | Active comparator | Drug: ARI-ORALPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Aripiprazole LauroxilAlso: Aristada12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through | Drug | AL-LAI: Long-Acting Injectable Antipsychotic |
| ARI-ORALAlso: aripiprazole, Abilifyoral aripiprazole | Drug | ARI-ORAL: Aripiprazole Oral Antipsychotic |
| AL-NCDAlso: Aristada InitioAripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release | Drug | AL-LAI: Long-Acting Injectable Antipsychotic |
Primary outcome
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
2 secondary outcomes
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
Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kenneth L Subotnik, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole Lauroxil, ARI-ORAL and AL-NCD in people with Schizophrenia and Schizoaffective Disorder, Depressive Type, run by University of California, Los Angeles at 1 site 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 28 Nov 2023). 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?
Exacerbation or Relapse of Psychotic Symptoms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.