CompletedNCT01529515Updated May 11, 2016Results posted

A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

A Phase 3 interventional study of PP3M 175 mg eq. and PP3M 263 mg eq. in Schizophrenia, sponsored by Janssen Research & Development, LLC. Completed at 53 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 509
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Read the detailed description

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Conditions studied

Schizophrenia

Browse trials for

Schizophrenia 3,539

Keywords

Schizophrenia
R092670
Paliperidone Palmitate
Paliperidone palmitate 3 month formulation (PP3M)

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 509 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Patients with schizophrenia for more than 1 year
A total score in the Positive and Negative Syndrome Scale (PANSS) \< 120
Signed informed consent
Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
Men must agree to use a double-barrier method of birth control
Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
A diagnosis of substance dependence within 6 months before screening
History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 509 participants (actual)

Study arms

Experimental
Paliperidone palmitate 3-month (PP3M)
Drug: PP3M 175 mg eq. · Drug: PP3M 263 mg eq. · Drug: PP3M 350 mg eq. · Drug: PP3M 525 mg eq.
Placebo comparator
Placebo
Drug: Placebo (20% Intralipid emulsion)

Interventions

DrugPP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
DrugPP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
DrugPP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
DrugPP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
DrugPlacebo (20% Intralipid emulsion)
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

What researchers measure

Primary outcomes

Time to Relapse During the Double-Blind Phase
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Time frame: Approximately Week 60

Secondary outcomes

Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Time frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Time frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of \<=30 had functioning so poor that he or she required intensive supervision.
Time frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)

Results

Posted Jun 18, 2015

Participant flow

TRANSITION PHASE

Participant flow — TRANSITION PHASE
Milestone	Open-Label Transition Phase: Paliperidone Palmitate 1-Month	Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Started	506	0	0	0
Completed	379	0	0	0
Not completed	127	0	0	0
Withdrew: Adverse event	16	0	0	0
Withdrew: Death	1	0	0	0
Withdrew: Lack of efficacy	19	0	0	0
Withdrew: Lost to follow-up	19	0	0	0
Withdrew: Protocol violation	4	0	0	0
Withdrew: Withdrawal by subject	51	0	0	0
Withdrew: Failed maintenance phase criteria	8	0	0	0
Withdrew: Other	9	0	0	0

MAINTENANCE PHASE

Participant flow — MAINTENANCE PHASE
Milestone	Open-Label Transition Phase: Paliperidone Palmitate 1-Month	Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Started	0	379	0	0
Completed	0	305	0	0
Not completed	0	74	0	0
Withdrew: Adverse event	0	10	0	0
Withdrew: Lack of efficacy	0	9	0	0
Withdrew: Lost to follow-up	0	5	0	0
Withdrew: Protocol violation	0	12	0	0
Withdrew: Withdrawal by subject	0	15	0	0
Withdrew: Failed randomization criteria	0	13	0	0
Withdrew: Other	0	10	0	0

DOUBLE BLIND PHASE

Participant flow — DOUBLE BLIND PHASE
Milestone	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Started	145	160
Completed	122	148
Not completed	23	12
Withdrew: Adverse event	1	0
Withdrew: Lost to follow-up	1	3
Withdrew: Pregnancy	1	0
Withdrew: Withdrawal by subject	10	7
Withdrew: Protocol violation	1	0
Withdrew: Other	9	2

Outcome measures

PrimaryTime to Relapse During the Double-Blind Phase

Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.

Time frame:: Approximately Week 60
Reported as:: Median · Days

Time to Relapse During the Double-Blind Phase
Days	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Time to Relapse During the Double-Blind Phase	395.0 (274.0 to NA)	NA (NA to NA)

SecondaryChange in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase

The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.

Time frame:: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Reported as:: Mean · Units on a Scale

Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Units on a Scale	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Baseline	54.3 ± 9.20	54.8 ± 9.96
Change at Endpoint (Approximately Week 60)	6.7 ± 14.40	-0.5 ± 8.36

SecondaryChange in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase

The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).

Time frame:: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Reported as:: Mean · Units on a Scale

Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Units on a Scale	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Baseline	2.8 ± 0.65	2.7 ± 0.68
Change at Endpoint (Approximately Week 60)	0.4 ± 0.87	0.1 ± 0.60

SecondaryChange in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase

The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of \<=30 had functioning so poor that he or she required intensive supervision.

Time frame:: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Reported as:: Mean · Units on a Scale

Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Units on a Scale	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
Baseline	68.5 ± 8.93	68.9 ± 9.34
Change at Endpoint (Approximately Week 60)	-4.2 ± 9.70	-0.5 ± 6.63

Adverse events

Collected over Up to Week 92. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Open-Label Phase: PP1M + PP3M	—	33/506 (6.5%)	317/506 (62.6%)
Double-Blind Phase: Placebo	—	15/145 (10.3%)	77/145 (53.1%)
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)	—	4/160 (2.5%)	98/160 (61.3%)

Most frequent serious events

Showing 10 of 23

Most frequent serious events
Event	Open-Label Phase: PP1M + PP3M	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
SchizophreniaPsychiatric disorders	12/506	11/145	1/160
Psychotic DisorderPsychiatric disorders	9/506	0/145	0/160
Suicide AttemptPsychiatric disorders	0/506	0/145	2/160
CellulitisInfections and infestations	0/506	1/145	0/160
Transaminases IncreasedInvestigations	0/506	1/145	0/160
AnxietyPsychiatric disorders	1/506	1/145	0/160
Suicidal IdeationPsychiatric disorders	2/506	1/145	0/160
Schizophrenia, Paranoid TypePsychiatric disorders	1/506	0/145	1/160
Hallucination, AuditoryPsychiatric disorders	2/506	0/145	0/160
Gastritis ErosiveGastrointestinal disorders	1/506	0/145	0/160

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	Open-Label Phase: PP1M + PP3M	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
InsomniaPsychiatric disorders	50/506	17/145	11/160
AnxietyPsychiatric disorders	43/506	15/145	13/160
Weight IncreasedInvestigations	51/506	5/145	14/160
HeadacheNervous system disorders	33/506	6/145	14/160
Injection Site PainGeneral disorders	44/506	0/145	2/160
Weight DecreasedInvestigations	8/506	11/145	2/160
NasopharyngitisInfections and infestations	14/506	2/145	9/160
SchizophreniaPsychiatric disorders	4/506	8/145	1/160
AkathisiaNervous system disorders	17/506	1/145	7/160
Upper Respiratory Tract InfectionInfections and infestations	9/506	3/145	6/160

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)	Total
Mean	38.5 ± 11.16	37.1 ± 10.87	37.8 ± 11.01

Sex: Female, Male
Sex: Female, Male(Participants)	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)	Total
Female	35	42	77
Male	110	118	228

Region of Enrollment
Region of Enrollment(participants)	Double-Blind Phase: Placebo	Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)	Total
Colombia	12	13	25
Malaysia	11	12	23
Mexico	10	8	18
Romania	14	13	27
South Korea	4	2	6
Turkey	5	6	11
Ukraine	63	74	137
United States	26	32	58

Study locations

53 sites

Little Rock, Arkansas, United States
San Fran Cisco, California, United States
Washington D.C., District of Columbia, United States
Lauderhill, Florida, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Flowood, Mississippi, United States
Marlton, New Jersey, United States
Cedarhurst, New York, United States
Oklahoma City, Oklahoma, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Barranquilla, Colombia
Bogotá, Colombia
Medellín, Colombia
Pereira, Colombia
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Tanjong Rambutan, Malaysia
Guadajalara, Mexico
Mexico City, Mexico
Monterrey, Mexico
San Luis Potosí City, Mexico
Zapopan, Mexico
Arad, Romania
Craiova, Romania
Iași, Romania
Sibiu, Romania
Tg Mures, Romania
Deajun, South Korea
Gyeongsangnam-Do, South Korea
Incheon, South Korea
Seongnam, South Korea
Diyarbakır, Turkey (Türkiye)
Sakarya, Turkey (Türkiye)
Donetsk, Ukraine
Evpatoriya, Ukraine
Hlevakha, Ukraine
Ivano-Frankivsk, Ukraine
Kerch, Ukraine
Kharkiv, Ukraine
Kherson, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Smila, Ukraine
Ternopil, Ukraine
Uzhhorod, Ukraine
Vinnitsa, Ukraine

References and documents

Publications

Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020. PubMed 32606705 ↗
Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153. PubMed 30994855 ↗
Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308. PubMed 28640988 ↗
Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3. PubMed 27743205 ↗
Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2. PubMed 26306819 ↗
Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241. PubMed 25820612 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2015, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 6, 2012
First posted: Feb 9, 2012
Start: May 2012
Primary completionActual: Apr 2014
CompletionActual: Apr 2014
Results first posted: Jun 18, 2015
Last update: May 11, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01529515
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Feb 9, 2012
Start date: May 2012
Primary completion: Apr 2014
Completion: Apr 2014
Results posted: Jun 18, 2015
Last update: May 11, 2016

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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