Trial Outcomes & Findings for Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (NCT NCT04203056)
NCT ID: NCT04203056
Last Updated: 2023-11-28
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
12 months
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
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.
ARI-ORAL: oral aripiprazole
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Baseline characteristics by cohort
| Measure |
AL-LAI: Long-Acting Injectable Antipsychotic
n=6 Participants
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
ARI-ORAL: Aripiprazole Oral Antipsychotic
n=9 Participants
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.
ARI-ORAL: oral aripiprazole
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
25.9 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
24.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber 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
Outcome measures
| Measure |
AL-LAI: Long-Acting Injectable Antipsychotic
n=6 Participants
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
ARI-ORAL: Aripiprazole Oral Antipsychotic
n=9 Participants
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.
ARI-ORAL: oral aripiprazole
|
|---|---|---|
|
Exacerbation or Relapse of Psychotic Symptoms
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: mean change from baseline to the 12 month pointPopulation: Fewer subjects analyzed than enrolled because only 6 subjects reached the 12 month point and had role functioning data availabe prior to study discontinuation.
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
Outcome measures
| Measure |
AL-LAI: Long-Acting Injectable Antipsychotic
n=2 Participants
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
ARI-ORAL: Aripiprazole Oral Antipsychotic
n=4 Participants
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.
ARI-ORAL: oral aripiprazole
|
|---|---|---|
|
Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
|
4.3 score on a scale
Standard Error .97
|
.06 score on a scale
Standard Error .97
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
AL-LAI: Long-Acting Injectable Antipsychotic
n=4 Participants
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
ARI-ORAL: Aripiprazole Oral Antipsychotic
n=5 Participants
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.
ARI-ORAL: oral aripiprazole
|
|---|---|---|
|
Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
|
9.3 Change score: change in T scores
Standard Error 2.2
|
4.6 Change score: change in T scores
Standard Error 2.5
|
Adverse Events
AL-LAI: Long-Acting Injectable Antipsychotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARI-ORAL: Aripiprazole Oral Antipsychotic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AL-LAI: Long-Acting Injectable Antipsychotic
n=6 participants at risk
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).
Aripiprazole Lauroxil: 12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through AL-NCD: Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
|
ARI-ORAL: Aripiprazole Oral Antipsychotic
n=9 participants at risk
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.
ARI-ORAL: oral aripiprazole
|
|---|---|---|
|
Psychiatric disorders
Arrest
|
0.00%
0/6 • Adverse event data were collected from the time of enrollment (signing the informed consent form) until completing the 12 month protocol or withdrawing early.
Note: 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. Therefore, Adverse events are not separated according to starting dosage. In any case, there were no serious adverse events to report for patients in the AL-LAI arm of the study.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of enrollment (signing the informed consent form) until completing the 12 month protocol or withdrawing early.
Note: 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. Therefore, Adverse events are not separated according to starting dosage. In any case, there were no serious adverse events to report for patients in the AL-LAI arm of the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Subotnik, PhD
University of California, Los Angeles
Phone: 3108250334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place