Schizophrenia
Conditions
Keywords
Alkermes, ARISTADA, Aripiprazole Lauroxil, Schizophrenia
Brief summary
This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
Interventions
Monthly IM injection
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole * Has a diagnosis of schizophrenia * Is clinically stable * Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening. * Has no antipsychotic medication regimen change for 4 weeks prior to Day 1 * Agreed to abide by the contraceptive requirements o the protocol * Resides in a stable living situation * Additional criteria may apply
Exclusion criteria
* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study * Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening * Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product * Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores | Up to 7 months | The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores | Up to 7 months | The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). |
| Number of Participants With Adverse Events | Up to 7 months | — |
| Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) | Up to 7 months | The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). |
| Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Up to 7 months | Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. |
| Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) | Up to 7 months | The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit. |
Countries
United States
Participant flow
Recruitment details
Subjects had schizophrenia, and had been taking paliperidone palmitate (PP) or Risperidone long-acting injection (RLAI) with inadequate results for at least 3 doses prior to screening.
Pre-assignment details
All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole Lauroxil Intramuscular (IM) injection
Aripiprazole Lauroxil: Monthly IM injection | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Moved out of area | 2 |
| Overall Study | Out of window for study visits | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Aripiprazole Lauroxil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 11.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 51 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 3 / 51 |
| serious Total, serious adverse events | 5 / 51 |
Outcome results
Primary
Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.
Time frame: Up to 7 months
Population: Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole Lauroxil | Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores | -0.2 units on a scale | Standard Deviation 0.87 |
p-value: 0.078t-test, 2 sided
Secondary
Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).
Time frame: Up to 7 months
Population: Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole Lauroxil | Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores | -2.7 units on a scale | Standard Deviation 9.21 |
Secondary
Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit.
Time frame: Up to 7 months
Population: Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole Lauroxil | Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) | -3.2 units on a scale | Standard Deviation 12.94 |
Secondary
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.
Time frame: Up to 7 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole Lauroxil | Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Spent at least 1 overnight as an inpatient | 3 participants |
| Aripiprazole Lauroxil | Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Attended an outpatient visit for mental health | 17 participants |
| Aripiprazole Lauroxil | Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Had at least 1 visit to an ER | 6 participants |
| Aripiprazole Lauroxil | Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Were arrested, picked up, or transported by police | 2 participants |
Secondary
Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).
Time frame: Up to 7 months
Population: Subjects who had at least one dose of study drug and had a last on-treatment visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole Lauroxil | Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) | 0.4 units on a scale | Standard Deviation 13.11 |
Secondary
Number of Participants With Adverse Events
Time frame: Up to 7 months
Population: Safety population includes all subjects who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aripiprazole Lauroxil | Number of Participants With Adverse Events | 21 Participants |