SchizophreniaPhase 4NCT01193166
Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
A Phase 4 study testing paliperidone palmitate, risperidone and olanzapine in people with Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
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 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital. 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 palmitate, risperidone and olanzapine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
- Have a current diagnosis of schizophrenia
- Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
- 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
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- have an unstable medical illness
- Women who are pregnant or breast-feeding, or planning to become pregnant
- Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
Show all 9Show fewer
- Received treatment with clozapine within 3 months of screening
- Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
- homeless at time of stuyd consent
About this study
Official title: A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
Read the detailed description
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
- Conditions
- Schizophrenia
- Being tested
- paliperidone palmitate, risperidone, olanzapine, aripiprazole, haloperidole
- 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.
paliperidone palmitateDrug
78, 117, 156, or 234 mg monthly injection for 12 months
risperidoneDrug
flexible dosing as prescribed by the study doctor for 12 months
olanzapineDrug
flexible dosing as prescribed by the study doctor for 12 months
aripiprazoleDrug
flexible dosing as prescribed by the study doctor for 12 months
haloperidoleDrug
flexible dosing as prescribed by the study doctor for 12 months
quetiapineDrug
flexible dosing as prescribed by the study doctor for 12 months
perphenazineDrug
flexible dosing as prescribed by the study doctor for 12 months
paliperidoneDrug
flexible dosing as prescribed by the study doctor for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months Receives: Drug: paliperidone palmitate |
| 002 | Active comparator | olanzapine flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: olanzapine |
| 003 | Active comparator | paliperidone flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: paliperidone |
| 004 | Active comparator | aripiprazole flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: aripiprazole |
| 005 | Active comparator | haloperidole flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: haloperidole |
| 006 | Active comparator | perphenazine flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: perphenazine |
| 007 | Active comparator | quetiapine flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: quetiapine |
| 008 | Active comparator | risperidone flexible dosing as prescribed by the study doctor for 12 months Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
Measured: Up to 12 months
Secondary outcomes (4)
Change in Clinical Global Impression-Severity score
Measured: Up to 12 months
Change in Global Assessment of Functionality score
Measured: Up to 12 months
Change in Medication Satisfaction Questionnaire score
Measured: Up to 12 months
Proportion of subjects with at least one psychiatric hospitalization
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: This study was stopped due to an internal reconsideration of priorities of the product portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193166
- Sponsor's protocol ID
- CR017110
- Other IDs
- R092670SCH4003
- Status last verified
- Jul 2013
- First submitted
- 30 Aug 2010
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
PubMed 38958149
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
- ClinicalTrials.gov ID
- NCT01193166
- Acronym / sponsor ID
- CR017110
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was stopped due to an internal reconsideration of priorities of the product portfolio.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
Detailed description
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: paliperidone palmitatepaliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months |
| 002 | Active comparator | Drug: olanzapineolanzapine flexible dosing as prescribed by the study doctor for 12 months |
| 003 | Active comparator | Drug: paliperidonepaliperidone flexible dosing as prescribed by the study doctor for 12 months |
| 004 | Active comparator | Drug: aripiprazolearipiprazole flexible dosing as prescribed by the study doctor for 12 months |
| 005 | Active comparator | Drug: haloperidolehaloperidole flexible dosing as prescribed by the study doctor for 12 months |
| 006 | Active comparator | Drug: perphenazineperphenazine flexible dosing as prescribed by the study doctor for 12 months |
| 007 | Active comparator | Drug: quetiapinequetiapine flexible dosing as prescribed by the study doctor for 12 months |
| 008 | Active comparator | Drug: risperidonerisperidone flexible dosing as prescribed by the study doctor for 12 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
- Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
- Have a current diagnosis of schizophrenia
- Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
- 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
Key exclusion criteria (9 listed)
- Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
- Actively abusing intravenous drugs
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- have an unstable medical illness
- Women who are pregnant or breast-feeding, or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paliperidone palmitate78, 117, 156, or 234 mg monthly injection for 12 months | Drug | 001 |
| risperidoneflexible dosing as prescribed by the study doctor for 12 months | Drug | 008 |
| olanzapineflexible dosing as prescribed by the study doctor for 12 months | Drug | 002 |
| aripiprazoleflexible dosing as prescribed by the study doctor for 12 months | Drug | 004 |
| haloperidoleflexible dosing as prescribed by the study doctor for 12 months | Drug | 005 |
| quetiapineflexible dosing as prescribed by the study doctor for 12 months | Drug | 007 |
| perphenazineflexible dosing as prescribed by the study doctor for 12 months | Drug | 006 |
| paliperidoneflexible dosing as prescribed by the study doctor for 12 months | Drug | 003 |
Primary outcome
Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
Time frame: Up to 12 months
4 secondary outcomes
Change in Clinical Global Impression-Severity score
Time frame: Up to 12 months
Change in Global Assessment of Functionality score
Time frame: Up to 12 months
Change in Medication Satisfaction Questionnaire score
Time frame: Up to 12 months
Proportion of subjects with at least one psychiatric hospitalization
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Derived from this study: PubMed 38958149Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paliperidone palmitate, risperidone and olanzapine in people with Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services (time frame: Up to 12 months). 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 NCT01193166, which also lists 1 linked publication.
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 8 Jul 2013.