NCT01157351|CompletedPhase 4Results

15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated

Janssen Scientific Affairs, LLC ClinicalTrials.gov

Compare

2 other identifiers

CR015625R092670SCH3006

Study Type

interventional

Target

450

Locations

2 countries

Sites

Timeline

RegisteredJul 2010

StartedMay 2010

CompletionDec 2013

Brief Summary

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline

Completed

Started May 2010

Typical duration for phase_4 schizophrenia

Geographic Reach

2 countries

56 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

1 year until next milestone

Results Posted

Study results publicly available

December 4, 2014

Completed

Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

May 3, 2010

Results QC Date

November 28, 2014

Last Update Submit

April 7, 2015

Conditions

Schizophrenia

Keywords

SchizophreniaRisperidoneRisperdalPaliperidone palmitateAripiprazoleHaloperidolOlanzapinePaliperidonePerphenazineQuetiapine

Outcome Measures

Primary Outcomes (2)

Time to First Treatment Failure
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
From date of randomization up to Month 15
Percentage of Participants in Each Event Category of First Treatment Failure
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
From date of randomization up to Month 15

Secondary Outcomes (4)

Time to First Psychiatric Hospitalization or Arrest/Incarceration
From date of randomization up to Month 15
Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
Baseline up to Month 15
Time to First Psychiatric Hospitalization
From date of randomization up to Month 15
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
Baseline up to Month 15

Study Arms (8)

001

EXPERIMENTAL

paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months

Drug: paliperidone palmitate

002

ACTIVE COMPARATOR

aripiprazole flexible dosing as prescribed by the study doctor for 15 months

Drug: aripiprazole

003

ACTIVE COMPARATOR

haloperidole flexible dosing as prescribed by the study doctor for 15 months

Drug: haloperidole

004

ACTIVE COMPARATOR

olanzapine flexible dosing as prescribed by the study doctor for 15 months

Drug: olanzapine

005

ACTIVE COMPARATOR

paliperidone flexible dosing as prescribed by the study doctor for 15 months

Drug: paliperidone

006

ACTIVE COMPARATOR

perphenazine flexible dosing as prescribed by the study doctor for 15 months

Drug: perphenazine

007

ACTIVE COMPARATOR

quetiapine flexible dosing as prescribed by the study doctor for 15 months

Drug: quetiapine

008

ACTIVE COMPARATOR

risperidone flexible dosing as prescribed by the study doctor for 15 months

Drug: risperidone