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Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

NCT03172871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2020-12-29

No results posted yet for this study

Summary

This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.

Conditions

Interventions

DRUG

Aripiprazole IM Depot

Aripiprazole IM depot 400 mg/300 mg (when not tolerated)

DRUG

Aripiprazole tablet

Oral aripiprazole tablets 10 to 20 mg daily

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Patyman Juma · Otsuka Beijing Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2019-07-22
Completion
2019-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172871 on ClinicalTrials.gov