Ignite Creation Date:
2025-12-18 @ 8:47 AM
Ignite Modification Date:
2025-12-23 @ 8:46 PM
Study NCT ID:
NCT03172871
Status:
None
Last Update Posted:
2020-12-29 00:00:00
First Post:
2017-05-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia
Sponsor:
None
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia
Status:
None
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Screening Phase: The screening phase will begin when informed consent is signed and be a maximum of 13 days. The investigators will assess the subjects who meet all eligibility criteria and collect the characteristic information of the subjects, such as demographic, medical history, etc. If subjects have been exposed to aripiprazole in the past (ie, tolerability has been established), then subjects will enter a washout period for 3～7 days from prior antipsychotic medications and other prohibited concomitant medications. If the investigator may reasonably verify that subject has been off antipsychotics for at least 3～7 days and has a history of tolerating aripiprazole, then the subject may have a screening phase of \< 7 days as long as the subject has had at least a 3～7-day washout phase from other antipsychotic medications. Subjects are required to be hospitalized during the entire screening phase.
12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo.
Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.
12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo.
Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: