Phase 2 Completed N=266 Randomized Treatment

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Schizophrenia · Bipolar I Disorder

Source: ClinicalTrials.gov NCT04030143 ↗

Enrolled (actual)

266

Serious AEs

5.3%

Results posted

Nov 2023

Primary outcomePrimary: Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) — 94; 95 Participants

Summary

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	94; 95	—
PRIMARY Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	0; 1; 2; 1; 1; 2	—
PRIMARY Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	0; 2; 0; 2; 13; 10	—
PRIMARY Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	1; 2; 0; 2; 12; 1	—
PRIMARY Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score	0.2; 0.2; -0.0; 0.1	—
PRIMARY Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score	0.1; 0.1; 0.0; -0.1	—
PRIMARY Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score	0.1; 0.1; 0.1; 0.1	—
PRIMARY Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg	1.0; 3.7; 1.0; 1.4; 1.0; 2.0	—
PRIMARY VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	1.6; 3.0; 1.5; 1.6; 0.8; 1.2	—
PRIMARY Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection	11; 2; 5; 5; 5; 3	—
PRIMARY Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection	7; 3; 7; 1; 3; 1	—
PRIMARY Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	4; 4	—
PRIMARY Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose	250	—
PRIMARY Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose	257	—
PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg	7760; 7840	—
PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg	14700	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg	286; 342	—
SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg	8.58; 28.0	—
SECONDARY AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg	9180	—
SECONDARY Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg	165	—
SECONDARY AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg	7190	—
SECONDARY Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg	7500	—
SECONDARY Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg	63.4	—
SECONDARY Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg	280; 339; 344	—
SECONDARY Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg	9.04; 6.97; 4.07	—
SECONDARY AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg	5030	—
SECONDARY Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg	112	—
SECONDARY PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg	48.3	—
SECONDARY Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg	221	—
SECONDARY Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg	229	—
SECONDARY Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score	-2.6; -1.7	—
SECONDARY Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score	-0.3; -0.1	—
SECONDARY Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score	3.4; 3.5	—
SECONDARY Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score	3.2; 0.5	—
SECONDARY Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-3.5; -3.3	—
SECONDARY Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	-1.9; -4.7	—
SECONDARY Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score	-0.2; -0.6	—

Eligibility Criteria

Inclusion Criteria

A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Body mass index of 18 to 35 kilograms per meter square (kg/m^2).
On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.

Exclusion Criteria

Participants who have:
Met DSM-5 criteria for substance use disorder within the past 180 days.
A positive drug screen for drugs of abuse
Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
Participants currently in an acute relapse of schizophrenia.
Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
Participants deemed intolerant of receiving injections.
Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04030143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.