Phase 3
N=337
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
Schizophrenia · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02431702 ↗Enrolled (actual)
337
Serious AEs
7.5%
Results posted
Jan 2021
Primary outcome: Primary: Part-2 (Disease Progression): Time to First Treatment Failure — NA; NA days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug); Haloperidol (Drug); Olanzapine (Drug); Oral Paliperidone ER (Drug); Perphenazine (Drug); Quetiapine (Drug); Oral Risperidone (Drug); Paliperidone Palmitate Injection (PP1M) (Drug); Paliperidone Palmitate Injection (PP3M) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Scientific Affairs, LLC
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part-2 (Disease Progression): Time to First Treatment Failure |
NA; NA | — |
| PRIMARY Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score |
1.6; 3.2 | — |
| PRIMARY Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score |
-0.7; -0.2; 0.5 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score |
2.0; 2.8 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score |
2.5; 2.9 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI) |
-0.001; -0.004 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain |
-0.2; -0.8 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain |
1.3; 1.0 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain |
1.8; 3.5 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain |
3.2; 0.7 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain |
1.3; 1.4 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain |
0.2; 2.8 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain |
0.3; 1.6 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score |
-0.2; -0.3 | — |
| SECONDARY Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS) |
7; 19; 29; 73; 14; 33 | — |
| SECONDARY Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score |
-0.2; 0.1 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score |
7.5; 7.0 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI) |
-0.001; -0.003 | — |
| SECONDARY Part 3 (EDP): Time to First Treatment Failure |
NA; NA | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain |
-1.7; 0.7 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain |
0.3; 0.8 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain |
2.5; 4.9 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain |
2.4; 0.7 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain |
0.2; -0.2 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain |
3.4; 4.7 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain |
-0.2; 1.4 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score |
-0.7; -0.7 | — |
| SECONDARY Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS |
3; 8; 27; 29; 11; 10 | — |
| SECONDARY Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score |
0.3; 0.4 | — |
| SECONDARY Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score |
67.6; 66.1; 66.6 | — |
| SECONDARY Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI) |
-0.7; -0.2; 0.5 | — |
Summary
The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP [that is oral paliperidone extended release {ER}, oral risperidone, or another OAP]) in delaying time to treatment failure. The study will also evaluate changes in cognition, functioning, brain intracortical myelin (ICM) volume following treatment with PP compared with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.
Eligibility Criteria
Inclusion Criteria
- Participant must have a current diagnosis of schizophrenia (295.90) or schizophreniform disorder (295.40) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 Disorders (SCID) with a first psychotic episode within the last 24 months prior to the screening visit
- Participant requires treatment with an antipsychotic medication
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
- Participant must have available a designated individual (example, family member, significant other, friend) who has knowledge of the participant and is generally aware of the participants daily activities, and who agrees to let the study site personnel know of changes in the participants circumstances when the participant is not able to provide this information. The designated individual must sign an informed consent form
- Participant is anticipated to have a stable place of residence for the duration of the trial
Exclusion Criteria
- Participant has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities
- Participant meets the DSM-5 definition of moderate or severe substance use disorder (except for nicotine) within 2 months prior to Screening
- Participant has a history of neuroleptic malignant syndrome
- Participant has received long-acting injectable (LAI) medication within 2 injection cycles prior to the Screening visit
- Participant has mental retardation, defined as pre-morbid intelligence quotient (IQ) as measured by Wechsler Test of Adult Reading at Screening less than (<) 70
Data sourced from ClinicalTrials.gov (NCT02431702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.