Trial Outcomes & Findings for A Study of Paliperidone Palmitate 6-Month Formulation (NCT NCT04072575)

Last Updated: 2025-04-29

Results Overview

Number of participants with relapse were reported. Relapse is defined as one or more of the following: a) Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms); b) Emergency Department/Room/Ward visit due to a worsening of the participant's symptoms of schizophrenia, but a psychiatric hospitalization does not occur; c) The participant inflicts deliberate self-injury or exhibits violent behaviour resulting in suicide, clinically significant injury to him/herself or another person, or significant property damage; d) The participant has suicidal or homicidal ideation and aggressive behaviour that is clinically significant (in frequency and severity) in the investigator's judgment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

178 participants

Primary outcome timeframe

Up to Day 730

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Overall Study STARTED	178
Overall Study COMPLETED	154
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Overall Study Physician Decision	1
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	14
Overall Study Other	2

Baseline Characteristics

A Study of Paliperidone Palmitate 6-Month Formulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=178 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Age, Continuous	40.4 years STANDARD_DEVIATION 10.76 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	176 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 730

Population: The intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of study drug in this study.

Outcome measures

Outcome measures
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=178 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Number of Participants With Relapse	7 Participants

PRIMARY outcome

Timeframe: Up to Day 730

Population: The safety analysis population included all participants who received at least 1 dose of study drug in this study.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events if they started after administration of the first dose and until 183 days after the last dose of study medication.

Outcome measures

Outcome measures
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=178 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	111 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 730

Population: The ITT analysis population included all participants who received at least 1 dose of study drug in this study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure.

Change from baseline in CGI-S scale score was reported. CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill participants. A higher score implies a more severe condition.

Outcome measures

Outcome measures
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=176 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score	0.0 Units on a scale Standard Deviation 0.51 • Interval 0.51 to

SECONDARY outcome

Timeframe: Baseline up to Day 730

Change from baseline in PSP scale score was reported. The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 had mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance.

Outcome measures

Outcome measures
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=173 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Change From Baseline in Personal and Social Performance (PSP) Scale Score	0.5 Units on a scale Standard Deviation 7.47 • Interval 7.47 to

SECONDARY outcome

Timeframe: Baseline up to Day 730

Change from baseline in PANSS total score were reported. The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale of 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).

Outcome measures

Outcome measures
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=173 Participants Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	0.7 Units on scale Standard Deviation 8.22 • Interval 8.22 to

Adverse Events

Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.

Serious events: 8 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=178 participants at risk Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.56% 1/178 • Number of events 1 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Peritoneum	0.56% 1/178 • Number of events 1 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Psychiatric disorders Hallucination, Auditory	0.56% 1/178 • Number of events 1 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Psychiatric disorders Psychiatric Symptom	0.56% 1/178 • Number of events 1 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Psychiatric disorders Schizophrenia	2.2% 4/178 • Number of events 4 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Renal and urinary disorders Nephrotic Syndrome	0.56% 1/178 • Number of events 1 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.

Other adverse events

Other adverse events
Measure	Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. n=178 participants at risk Participants who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (NCT03345342) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
Endocrine disorders Hyperprolactinaemia	7.3% 13/178 • Number of events 13 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Gastrointestinal disorders Diarrhoea	6.2% 11/178 • Number of events 12 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Infections and infestations Nasopharyngitis	5.1% 9/178 • Number of events 11 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Investigations Blood Prolactin Increased	10.7% 19/178 • Number of events 19 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Investigations Weight Increased	5.1% 9/178 • Number of events 9 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.
Nervous system disorders Headache	13.5% 24/178 • Number of events 30 • Up to Day 730 The safety analysis population included all participants who received at least 1 dose of study drug in this study.

Additional Information

Director Clinical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER