Trial Outcomes & Findings for Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics (NCT NCT02360319)

NCT ID: NCT02360319

Last Updated: 2020-12-02

Results Overview

Assessments are done using best available data and patient interviews

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 489 participants
• Primary outcome timeframe: Hospitalizations assessed every 2 months from baseline to Month 24
• Results posted on: 2020-12-02

Participant Flow

Participant milestones

Measure	Clinician's Choice Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Overall Study STARTED	255	234
Overall Study COMPLETED	167	173
Overall Study NOT COMPLETED	88	61

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics

Baseline characteristics by cohort

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation	Total n=489 Participants Total of all reporting groups
Age, Continuous	24.7 years STANDARD_DEVIATION 4.1 • n=5 Participants	25.7 years STANDARD_DEVIATION 4.3 • n=7 Participants	25.2 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	172 Participants n=7 Participants	368 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	6 Participants n=7 Participants	18 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	104 Participants n=5 Participants	109 Participants n=7 Participants	213 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	80 Participants n=7 Participants	171 Participants n=5 Participants
Race (NIH/OMB) More than one race	45 Participants n=5 Participants	39 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	255 participants n=5 Participants	234 participants n=7 Participants	489 participants n=5 Participants

PRIMARY outcome

Timeframe: Hospitalizations assessed every 2 months from baseline to Month 24

Population: Intent to treat

Assessments are done using best available data and patient interviews

Outcome measures

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Time to First Hospitalization	530.6 days Interval 497.3 to 563.9	613.7 days Interval 582.3 to 645.1

SECONDARY outcome

Timeframe: Measured every 2 months from baseline to month 24

Population: Intent to treat

Assessments are completed using best available data and patient interviews

Outcome measures

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Total Number of Psychiatric Hospitalizations Per Treatment Arm	208 Hospitalizations	133 Hospitalizations

SECONDARY outcome

Timeframe: Measured at Month 12 and Month 24

The Brief Psychotic Rating Scale is an 18 item scale where each item is rated 1-7, the minimum total score is 18 and the maximum total score is 126. Higher scores indicate more severe symptoms.

Outcome measures

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Brief Psychotic Rating Scale (BPRS) Total Score Baseline	35.59 Scores on a scale Standard Deviation 9.40	35.45 Scores on a scale Standard Deviation 9.27
Brief Psychotic Rating Scale (BPRS) Total Score Month 12	30.7 Scores on a scale Standard Deviation 8.73	31.31 Scores on a scale Standard Deviation 9.32
Brief Psychotic Rating Scale (BPRS) Total Score Month 24	30.73 Scores on a scale Standard Deviation 8.86	30.87 Scores on a scale Standard Deviation 9.13

SECONDARY outcome

Timeframe: Measured at Month 12 and Month 24

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a 12 item scale with a total score range of 0 to 321 with higher scores indicating better cognitive functioning

Outcome measures

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores Baseline	182.4 Scores on a scale Standard Deviation 33.1	177.7 Scores on a scale Standard Deviation 35.4
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores Month 12	189.2 Scores on a scale Standard Deviation 34.9	178.2 Scores on a scale Standard Deviation 34.9
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores Month 24	194.1 Scores on a scale Standard Deviation 33.2	180.8 Scores on a scale Standard Deviation 33.6

SECONDARY outcome

Timeframe: Measured at Month 12 and Month 24

Population: Intent to treat

Quality of Life (QLS) is a 21 item scale where each item is rated from 0 to 7, the minimum score is 0 and the maximum score is 126 with higher scores indicating better overall functioning.

Outcome measures

Measure	Clinician's Choice n=255 Participants Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=234 Participants Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Quality of Life (QLS) Total Score Month 24	62.21 Scores on a scale Standard Deviation 24.54	70.05 Scores on a scale Standard Deviation 24.28
Quality of Life (QLS) Total Score Baseline	63.60 Scores on a scale Standard Deviation 19.36	58.40 Scores on a scale Standard Deviation 19.83
Quality of Life (QLS) Total Score Month 12	68.45 Scores on a scale Standard Deviation 23.13	65.02 Scores on a scale Standard Deviation 21.60

Adverse Events

Clinician's Choice

Serious events: 104 serious events

Other events: 161 other events

Deaths: 2 deaths

Aripiprazole Once Monthly

Serious events: 68 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clinician's Choice n=241 participants at risk；n=255 participants at risk Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=222 participants at risk；n=234 participants at risk Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Cardiac disorders myocardial infarction	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Psychiatric hospitalization/illness	37.6% 96/255 • Number of events 231 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	25.6% 60/234 • Number of events 143 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Social circumstances Jail	0.78% 2/255 • Number of events 2 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Serious psychiatric event not requiring hospitalization	0.78% 2/255 • Number of events 2 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	1.3% 3/234 • Number of events 3 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
General disorders Confusion	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Gastrointestinal disorders Cholecystectomy	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Infections and infestations Abcess	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Gastrointestinal disorders Vomiting	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Blood and lymphatic system disorders Anemia	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Tachycardia	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Angina	0.39% 1/255 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.00% 0/234 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Hypertension	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.85% 2/234 • Number of events 5 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Reproductive system and breast disorders Lactation	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 4 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Social circumstances Drug Overdose	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Injury, poisoning and procedural complications Chest laceration	0.00% 0/255 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	0.43% 1/234 • Number of events 1 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.

Other adverse events

Measure	Clinician's Choice n=241 participants at risk；n=255 participants at risk Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years Any FDA approved antipsychotic agent: Investigators are free to choose the most appropriate treatment for their clients	Aripiprazole Once Monthly n=222 participants at risk；n=234 participants at risk Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years aripiprazole long acting injectable formulation
Metabolism and nutrition disorders Weight Gain	19.5% 47/241 • Number of events 47 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	14.4% 32/222 • Number of events 32 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Depression	8.3% 20/241 • Number of events 20 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	10.4% 23/222 • Number of events 23 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Anxiety	6.2% 15/241 • Number of events 15 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	12.2% 27/222 • Number of events 27 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Endocrine disorders Hyperprolactemia	12.9% 31/241 • Number of events 31 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	4.1% 9/222 • Number of events 9 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Elevated cholesterol levels	10.0% 24/241 • Number of events 24 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	6.8% 15/222 • Number of events 15 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Hepatobiliary disorders Hepatic enzyme abnormalities	9.1% 22/241 • Number of events 22 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	6.8% 15/222 • Number of events 15 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Insomnia	7.1% 17/241 • Number of events 17 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	8.6% 19/222 • Number of events 19 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Hypertension	7.5% 18/241 • Number of events 18 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	5.4% 12/222 • Number of events 12 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Somnolence	4.6% 11/241 • Number of events 11 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	7.2% 16/222 • Number of events 16 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Psychiatric disorders Hostility/aggression	2.9% 7/241 • Number of events 7 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	7.2% 16/222 • Number of events 16 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Cardiac disorders Tachycardia	5.0% 12/241 • Number of events 12 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	3.2% 7/222 • Number of events 7 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.
Nervous system disorders Restlessness	0.83% 2/241 • Number of events 2 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.	6.3% 14/222 • Number of events 14 • All Adverse Events, regardless of relationship to study drug or procedure, were collected beginning from the time the subject signs the study Informed Consent Form through the last Visit, scheduled at 104 weeks following the Baseline Visit. Serious AEs were collected for 30 days after the last dose or at the Follow-up Visit, whichever comes later.

Additional Information

Patrica Marcy

Vanguard Research Group

Phone: 3474398035

Email: pmarcy@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place