NCT01515423|CompletedPhase 3Results

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

Janssen Research & Development, LLC ClinicalTrials.gov

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4 other identifiers

CR100662R092670PSY30112011-004889-15U1111-1135-7054

Study Type

interventional

Target

1,429

Locations

25 countries

Sites

173

Timeline

RegisteredJan 2012

StartedMay 2012

CompletionMar 2015

Brief Summary

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,429

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline

Completed

Started May 2012

Typical duration for phase_3 schizophrenia

Geographic Reach

25 countries

173 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

2.8 years study duration

First Submitted

Initial submission to the registry

January 17, 2012

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed

Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

January 17, 2012

Results QC Date

February 1, 2016

Last Update Submit

April 28, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaR092670Paliperidone PalmitatePaliperidone palmitate 1 month formulation (PP1M)Paliperidone palmitate 3 month formulation (PP3M)

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Up to 48 weeks

Secondary Outcomes (6)

Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
DB Baseline (Week 17) and 48 week or DB Endpoint
Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
DB Baseline (Week 17) and 48 week or DB Endpoint
Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
DB Baseline (Week 17) and 48 week or DB Endpoint
Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Weeks 41 to 65
Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
DB Baseline (Week 17) and 48 week or DB Endpoint
+1 more secondary outcomes

Study Arms (2)

Paliperidone palmitate 3-month (PP3M)

EXPERIMENTAL

A formulation of paliperidone palmitate with a 3-month injection interval

Drug: PP3M 175 mg eq.Drug: PP3M 263 mg eq.Drug: PP3M 350 mg eq.Drug: PP3M 525 mg eq.Drug: Placebo (20% Intralipid)

Paliperidone palmitate 1-month (PP1M)

ACTIVE COMPARATOR

A formulation of paliperidone palmitate with a 1-month injection interval

Drug: PP1M 50 mg eq.Drug: PP1M 75 mg eq.Drug: PP1M 100 mg eq.Drug: PP1M 150 mg eq.

Interventions

PP3M 175 mg eq.DRUG

Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.