Schizophrenia (Recent-onset)Phase 4NCT01451736
Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
A Phase 4 study testing paliperidone palmitate and risperidone in people with Schizophrenia (Recent-onset), run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia (Recent-onset)
- What is being tested?
- paliperidone palmitate and risperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 31 Dec 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A first episode of a psychotic illness is occurring or did occur within the last 2 years;
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
- Between 18 and 45 years of age.
Who cannot join
- Neurological disorder (e.g., epilepsy) or significant head injury;
- Significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
- Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;
- Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
- Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or
- Patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095
About this study
Official title: Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia
This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia.
Read the detailed description
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer extrapyramidal side effects than older "typical" antipsychotics. Oral risperidone is an atypical antipsychotic medication that is very commonly used to control the symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major clinical issue. This study will determine the effectiveness of oral risperidone versus a long-acting injectible alternative, paliperidone palmitate, in treating people with first-episode schizophrenia. Impact on clinical symptoms and cognitive functioning will be examined.
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting paliperidone palmitate administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of paliperidone palmitate once every 4 weeks. Dosages will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient oral risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include psychiatrist monitoring of medication response and side effects; group therapy meetings focused on everyday living skills; family education about schizophrenia; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms, work recovery, and social functioning.
- Conditions
- Schizophrenia (Recent-onset)
- Being tested
- paliperidone palmitate, risperidone
- Keywords
- First-episode Schizophrenia, Schizoaffective Disorder, Depressed Type (recent-onset), Schizophreniform Disorder, oral risperidone, long-acting injectable paliperidone palmitate, functional outcome
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone palmitateDrug
Also called Invega Sustenna
long-acting injectable
risperidoneDrug
Also called Risperdal
oral
| Study group | Role | What they receive |
|---|---|---|
| paliperidone palmitate (Invega Sustenna) | Experimental | Participants will be provided paliperidone palmitate (Invega Sustenna), administered in injectible long-acting form, plus group skills training and case management Receives: Drug: paliperidone palmitate |
| oral risperidone | Active comparator | Participants will be provided oral risperidone, plus group skills training and case management Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation or relapse of psychotic symptoms
Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
Measured: Evaluated for 12 months
Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.
Measured: Baseline to 12 months
Role Functioning
Role Functioning Scale (RFS; Goodman et al. 1993).
Measured: Baseline to 12 months
Secondary outcomes (5)
Cognitive performance on test battery (MCCB)
The cognitive domain scores from the MATRICS Consensus Cognitive Battery (MCCB) will be used as secondary measures to identify the domains in which treatment effects occurred.
Measured: Measured at baseline and 12 months
Insight (Awareness of Mental Disorder)
Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
Measured: Measured at baseline and 12 months
Retention in treatment
Retention in treatment
Measured: Measured at 12 months
Social functioning
Social Functioning Scale (Goodman et al., 1993)
Measured: Baseline to 12 months
Emotional reactivity on psychophysiological measures
Emotional reactivity on psychophysiological measures
Measured: Measured at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
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 Schizophrenia (Recent-onset)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Keith Nuechterlein, Ph.D., University of California, Los Angeles
- Investigators
- Keith H Nuechterlein, Ph.D., Principal investigator, University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451736
- Sponsor's protocol ID
- P50 MH066286 Phase II
- Other IDs
- P50MH066286, R092670SCH4005
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2011
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Subotnik KL, Ventura J, McEwen SC, Turner LR, Sturdevant YR, Distler MG, Casaus LR, Zito MF, Hellemann GS, Sugar CA, Whelan FG, Niess TL, McGraw EA, Nuechterlein KH. Aerobic Exercise Enhances the Impact of Cognitive Training on Positive Symptoms After a First Episode of Schizophrenia. Behav Modif. 2025 Nov;49(5-6):430-449. doi: 10.1177/01454455251371021. Epub 2025 Sep 10.
PubMed 40928164
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT01451736
- Acronym / sponsor ID
- P50 MH066286 Phase II
- Conditions
- Schizophrenia (Recent-onset)
- Keywords
- First-episode Schizophrenia, Schizoaffective Disorder, Depressed Type (recent-onset), Schizophreniform Disorder, oral risperidone, long-acting injectable paliperidone palmitate, functional outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Janssen Scientific Affairs, LLC
- Study start
- Oct 2011
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Oct 2011 (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.
This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia.
Detailed description
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer extrapyramidal side effects than older "typical" antipsychotics. Oral risperidone is an atypical antipsychotic medication that is very commonly used to control the symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major clinical issue. This study will determine the effectiveness of oral risperidone versus a long-acting injectible alternative, paliperidone palmitate, in treating people with first-episode schizophrenia. Impact on clinical symptoms and cognitive functioning will be examined.
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting paliperidone palmitate administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of paliperidone palmitate once every 4 weeks. Dosages will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient oral risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include psychiatrist monitoring of medication response and side effects; group therapy meetings focused on everyday living skills; family education about schizophrenia; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms, work recovery, and social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paliperidone palmitate (Invega Sustenna) | Experimental | Drug: paliperidone palmitateParticipants will be provided paliperidone palmitate (Invega Sustenna), administered in injectible long-acting form, plus group skills training and case management |
| oral risperidone | Active comparator | Drug: risperidoneParticipants will be provided oral risperidone, plus group skills training and case management |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A first episode of a psychotic illness is occurring or did occur within the last 2 years;
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
- Between 18 and 45 years of age.
Key exclusion criteria (6 listed)
- Neurological disorder (e.g., epilepsy) or significant head injury;
- Significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
- Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;
- Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
- Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or
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 palmitateAlso: Invega Sustennalong-acting injectable | Drug | paliperidone palmitate (Invega Sustenna) |
| risperidoneAlso: Risperdaloral | Drug | oral risperidone |
Primary outcome
Exacerbation or relapse of psychotic symptoms
Time frame: Evaluated for 12 months
Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Time frame: Baseline to 12 months
The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.
Role Functioning
Time frame: Baseline to 12 months
Role Functioning Scale (RFS; Goodman et al. 1993).
5 secondary outcomes
Cognitive performance on test battery (MCCB)
Time frame: Measured at baseline and 12 months
Insight (Awareness of Mental Disorder)
Time frame: Measured at baseline and 12 months
Retention in treatment
Time frame: Measured at 12 months
Social functioning
Time frame: Baseline to 12 months
Emotional reactivity on psychophysiological measures
Time frame: Measured at baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 40928164Subotnik KL, Ventura J, McEwen SC, Turner LR, Sturdevant YR, Distler MG, Casaus LR, Zito MF, Hellemann GS, Sugar CA, Whelan FG, Niess TL, McGraw EA, Nuechterlein KH. Aerobic Exercise Enhances the Impact of Cognitive Training on Positive Symptoms After a First Episode of Schizophrenia. Behav Modif. 2025 Nov;49(5-6):430-449. doi: 10.1177/01454455251371021. Epub 2025 Sep 10.
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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.
Keith H Nuechterlein, Ph.D. principal investigator
University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paliperidone palmitate and risperidone in people with Schizophrenia (Recent-onset), run by University of California, Los Angeles at 1 site in United States.
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 3 inclusion and 6 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exacerbation or relapse of psychotic symptoms (time frame: Evaluated for 12 months). The study lists 3 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 NCT01451736, 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 11 Apr 2022.