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SchizophreniaPhase 4NCT01157351

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

A Phase 4 study testing paliperidone, risperidone and haloperidole in people with Schizophrenia, run by Janssen Scientific Affairs, LLC at 56 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
paliperidone, risperidone and haloperidole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
56 sitesin 2 countries
Study dates
May 2010to Dec 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
  • Must successfully answer all the questions on the Informed Consent quiz indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Have a current diagnosis of schizophrenia
  • Taking no more than 1 oral antipsychotic on the day before randomization
  • Have been placed into custody at least twice with one of them leading to incarceration within the 24 months previous to study start, with the last release occurring within the 90 days before the first day of screening
  • in the opinion of the investigator, may benefit from a change in their prior antipsychotic treatment
Show all 10Show fewer
  • Have available a designated individual (eg, family member, case manager, significant other, probation/parole officer) who has knowledge of the patient and is generally aware of the patient's daily activities, and who agrees to let the study site personnel know of changes in the patients circumstances when the patient is not able to provide this information, ie, arrests, protocol-defined hospitalizations, emergency room visits, becoming homeless, etc.
  • Have either an address or phone number where they can be reached, or be accessible to the designated individual
  • Must agree to receive regular injections for 15 months if randomly assigned to the paliperidone palmitate treatment group, or continue with oral study medication treatment for 15 months if randomly assigned to the oral antipsychotic treatment group
  • Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

Who cannot join

  • Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
  • Actively abusing intravenous drugs within the past 3 months or have an opiate dependence disorder
  • Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
  • Women who are pregnant or breast-feeding, or planning to become pregnant
  • Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
  • Received treatment with clozapine within 3 months of screening
  • Are at a high risk of violence in the next 15 months, in the opinion of the investigator
  • who have a history of sex offenses including felony sex offenses, child molestation

Trial locations and contacts

56 sites in 2 countries.

56 sites in 2 countries

United States55 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Bothell, Washington

  • Study site

    Buffalo, New York

  • Study site

    Bullhead City, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    DeSoto, Texas

  • Study site

    Escondido, California

  • Study site

    Flowood, Mississippi

  • Study site

    Glendale, California

  • Study site

    Hoffman Estates, Illinois

  • Study site

    Honolulu, Hawaii

  • Study site

    Imperial, California

  • Study site

    Irving, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Las Vegas, Nevada

  • Study site

    Leesburg, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Miami, Florida

  • Study site

    Miami Gardens, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Naperville, Illinois

  • Study site

    Nashville, Tennessee

  • Study site

    National City, California

  • Study site

    New Britain, Connecticut

  • Study site

    New London, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Paramus, New Jersey

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pico Rivera, California

  • Study site

    Riverside, California

  • Study site

    San Antonio, Texas

  • Study site

    San Bernadino, California

  • Study site

    San Diego, California

  • Study site

    San Fran Cisco, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Tamarac, Florida

  • Study site

    Tampa, Florida

  • Study site

    Tuscon, Arizona

  • Study site

    Wharton, Texas

  • Study site

    Wichita, Kansas

  • Study site

    Willingboro, New Jersey

  • Study site

    Willoughby, Ohio

  • Study site

    Witchita, Kansas

Other trials in United States

Puerto Rico1 site

  • Study site

    Rio Piedras

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the detailed description

The primary objective of this study is to compare the efficacy of paliperidone palmitate 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. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

Conditions
Schizophrenia
Being tested
paliperidone, risperidone, haloperidole, perphenazine, aripiprazole
Keywords
Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paliperidoneDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • risperidoneDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • haloperidoleDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • perphenazineDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • aripiprazoleDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • quetiapineDrug

    flexible dosing as prescribed by the study doctor for 15 months

  • paliperidone palmitateDrug

    78, 117, 156, or 234 mg monthly injection for 15 months

  • olanzapineDrug

    flexible dosing as prescribed by the study doctor for 15 months

Study groups in NCT01157351
Study groupRoleWhat they receive
001Experimentalpaliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months
Receives: Drug: paliperidone palmitate
002Active comparatoraripiprazole flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: aripiprazole
003Active comparatorhaloperidole flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: haloperidole
004Active comparatorolanzapine flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: olanzapine
005Active comparatorpaliperidone flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: paliperidone
006Active comparatorperphenazine flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: perphenazine
007Active comparatorquetiapine flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: quetiapine
008Active comparatorrisperidone flexible dosing as prescribed by the study doctor for 15 months
Receives: Drug: risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From date of randomization up to Month 15

  2. 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.

    Measured: From date of randomization up to Month 15

Secondary outcomes (4)

  1. Time to First Psychiatric Hospitalization or Arrest/Incarceration

    A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.

    Measured: From date of randomization up to Month 15

  2. Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration

    The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.

    Measured: Baseline up to Month 15

  3. Time to First Psychiatric Hospitalization

    A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."

    Measured: From date of randomization up to Month 15

  4. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration

    The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.

    Measured: Baseline up to Month 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01157351
Sponsor's protocol ID
CR015625
Other IDs
R092670SCH3006
Status last verified
Apr 2015
First submitted
3 May 2010
Last updated
24 Apr 2015
Data monitoring committee
No

Publications

  • Lopena OJ, Alphs LD, Sajatovic M, Turkoz I, Sun L, Johnston KL, Sliwa JK, Najarian DM, Starr HL. Earlier Use of Long-Acting Injectable Paliperidone Palmitate Versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis. J Clin Psychiatry. 2023 Sep 25;84(6):23m14788. doi: 10.4088/JCP.23m14788.

    PubMed 37756123

  • Bell Lynum KS, Henderson DC, Wright HJ, Gogate JP, Kim E. Treatment Effect With Paliperidone Palmitate Compared With Oral Antipsychotics in Black/African American Patients With Schizophrenia and a History of Criminal Justice System Involvement: A Post Hoc Analysis of the PRIDE Study. J Clin Psychiatry. 2021 Feb 23;82(2):20m13356. doi: 10.4088/JCP.20m13356.

    PubMed 33988924

  • Alphs L, Mao L, Lynn Starr H, Benson C. A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia. Schizophr Res. 2016 Feb;170(2-3):259-64. doi: 10.1016/j.schres.2015.12.012. Epub 2015 Dec 29.

    PubMed 26742509

  • Alphs L, Bossie C, Mao L, Lee E, Starr HL. Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent-onset versus more chronic schizophrenia and a history of criminal justice system involvement. Early Interv Psychiatry. 2018 Feb;12(1):55-65. doi: 10.1111/eip.12271. Epub 2015 Sep 25.

    PubMed 26403322

  • Alphs L, Benson C, Cheshire-Kinney K, Lindenmayer JP, Mao L, Rodriguez SC, Starr HL. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015 May;76(5):554-61. doi: 10.4088/JCP.14m09584.

    PubMed 25938474

  • Alphs L, Mao L, Rodriguez SC, Hulihan J, Starr HL. Design and rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study: a novel comparative trial of once-monthly paliperidone palmitate versus daily oral antipsychotic treatment for delaying time to treatment failure in persons with schizophrenia. J Clin Psychiatry. 2014 Dec;75(12):1388-93. doi: 10.4088/JCP.13m08965.

    PubMed 25375367

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing paliperidone, risperidone and haloperidole in people with Schizophrenia, run by Janssen Scientific Affairs, LLC at 56 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Treatment Failure (time frame: From date of randomization up to Month 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01157351, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.

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