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

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.

Timeline

Start

2019-08-01

Primary completion

2020-07-08

Completion

2020-07-08

Publications

• Citrome L, Such P, Yildirim M, Madera-McDonough J, Beckham C, Zhang Z, Larsen F, Harlin M. Safety and Efficacy of Aripiprazole 2-Month Ready-to-Use 960 mg: Secondary Analysis of Outcomes in Adult Patients With Schizophrenia in a Randomized, Open-label, Parallel-Arm, Pivotal Study. J Clin Psychiatry. 2023 Sep 4;84(5):23m14873. doi: 10.4088/JCP.23m14873.
• McIntyre RS, Such P, Yildirim M, Madera-McDonough J, Zhang Z, Larsen F, Harlin M. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study. Curr Med Res Opin. 2023 Jul;39(7):1021-1030. doi: 10.1080/03007995.2023.2219155. Epub 2023 Jun 9.
• Harlin M, Yildirim M, Such P, Madera-McDonough J, Jan M, Jin N, Watkin S, Larsen F. A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder. CNS Drugs. 2023 Apr;37(4):337-350. doi: 10.1007/s40263-023-00996-8. Epub 2023 Mar 24.

Drugs

Indications