SchizophreniaNCT01181960
Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
An observational study of Schizophrenia and Bipolar Disorder, run by Janssen Scientific Affairs, LLC at 34 sites in United States.
Trial summary
The purpose of this study is to build a data repository that can be used to understand pharmaceutical utilization patterns among patients being treated in community behavioral health organizations (CBHOs) for schizophrenia or bipolar I disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Risperidone long acting injectable - New Starts, Risperidone long acting injectable - Continuous Users and Paliperidone Palmitate -New and Continuous Users
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,066 participants
- Where
- 34 sitesUnited States
- Study dates
- Aug 2010to Nov 2013
- Phase
- Observational
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Potential participants will be identified by treating clinicians at the site. The study will enroll participants treated at participating sites for schizophrenia and bipolar I disorder. The study does not involve administration of a study drug, but will naturalistically follow partticipants in these medication cohorts at the time of enrollment: clinician ordered initiation or switch to LAT within past 4 weeks, clinician ordered initiation or switch to oral antipsychotic within past 4 weeks, continuous users ( greater than or equal to 6 months) of Risperdal long acting injectable, continuous users (greater than or equal to 1 month) of Invega Sustenna.
Who may be able to join
- Diagnosed with schizophrenia or bipolar I disorder
- Antipsychotic use in one of the following categories: Clinician ordered initiation of Risperidone long acting injectable in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- On continuous Risperidone long acting injectable for at least 6 months prior to enrollment (no gaps between injections>30 days)
- Clinician ordered initiation of Paliperidone Palmitate in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- or on continuous Paliperidone Palmitate for any time period prior to enrollment
- Clinician ordered initiation of another antipsychotic in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
Show all 10Show fewer
- Not enrolled in another clinical study
- Primary source of care for schizophrenia or bipolar I disorder is the recruiting CBHO
- Agrees to all study procedures/interviews
- must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Currently participating in a clinical study (e.g. clinical trial or observational study) or participated in a clinical study within the past 30 days
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Lehigh Valley Hospital Dept. of Psychiatry
Allentown, Pennsylvania, 18103
Institute for Health Evaluation and Research Unlimited [IHEARU]
Arlington, Texas, 76016
Aurora Mental Health Center
Aurora, Colorado, 80014
Medical Development Centers LLC (Baton Rouge)
Baton Rouge, Louisiana, 70808
Centerstone-Indiana Centerstone Research Institute
Bloomington, Indiana, 47401
Neuropsychiatry Clinic and Research Center
Bullhead City, Arizona, 86442
South Shore Mental Health Center
Charleston, Rhode Island, 02813
Shanti Clinical Trials
Colton, California, 92324
Carolina Behavioral Care - Durham [CAREMARK]
Durham, North Carolina, 27705
OCCMHA/Community Network Services, Inc.: Oakland County Community Mental Health Authority
Farmington Hills, Michigan, 48331
Cherry Street Health Services
Grand Rapids, Michigan, 49503
Carolina Behavioral Care - Henderson
Henderson, North Carolina, 27536
Carolina Behavioral Care - Hillsborough
Hillsborough, North Carolina, 27278
Sun Valley Research Center
Imperial, California, 92251
LifeStream Behavioral Center, Inc.
Leesburg, Florida, 34749
Premier Psychiatric Research Institute
Lincoln, Nebraska, 68526
River Edge Behavioral Health Center
Macon, Georgia, 31217
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101
APF Research
Miami, Florida, 33165
Centerstone-Tennessee Centerstone Research Institute
Nashville, Tennessee, 37228
South Coast Clinical Trials, Inc.
Norwalk, California, 90650
Medical Development Centers LLC (Opelousas)
Opelousas, Louisiana, 70570
Bergen Regional Medical Center
Paramus, New Jersey, 07652
St Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Human Service Center (Fayette Companies)
Pawtucket, Rhode Island, 61603
Human Service Center (Fayette Companies)
Peoria, Illinois, 61603
Family Services of Western Pennsylvania
Pittsburgh, Pennsylvania, 15238
Center for Health Care Services
San Antonio, Texas, 78229
Bootheel Counseling Services
Sikeston, Missouri, 63801
Frontier Institute-Research Department for Spokane Mental Health
Spokane, Washington, 99204
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
Burrell Behavioral Health
Springfield, Missouri, 65804
CenterPointe Institute of Research
St Louis, Missouri, 63128
Chestnut Ridge Counseling Services, Inc.
Uniontown, Pennsylvania, 15401
About this study
The purpose of this study is to build a data repository that can be used to understand pharmaceutical utilization patterns among patients being treated in community behavioral health organizations (CBHOs) for schizophrenia or bipolar I disorder.
Read the detailed description
This is a prospective observational study of usual care of patients undergoing treatment for schizophrenia or bipolar I disorder at CBHOs. Up to 50 CBHOs will be selected as sites for this study. Treating clinicians at these sites will notify the designated research coordinators for this study when they are initiating a patient on a new antipsychotic medication (including risperidone long acting injectable or paliperidone palmitate) or if they are treating a patient with risperidone long acting injectable or paliperidone palmitate. New initiation will include patients not previously on any antipsychotic medication as well as those switched from one antipsychotic to another. Switches may include but are not limited to switches among different types of oral antipsychotics, from an oral antipsychotic to Long Acting Therapy (LAT), or from LAT to an oral antipsychotic. Site research staff will screen potential participants identified by the clinicians and enroll those meeting study criteria who consent to study participation. Sites will maintain a screening log of all potential participants. The target enrollment for this study is up to 2,450 participants. Enrollment by cohort will be monitored and sites will be notified to stop enrollment if target enrollment for a particular cohort has been reached. Eligible participants who consent to the study will be recruited into one of two samples: participants with a schizophrenia diagnosis (target n=2,250) and participants with a bipolar I disorder diagnosis (target n=200). There will be four cohorts: risperidone long acting injectable new starts (target n=475); risperidone long acting injectable continuous users (target n=75); paliperidone palmitate new starts or continuous users (target n=1,200); and other antipsychotic new starts (target n=700). During the entire study follow-up period participants will receive their medication per usual care in their treatment setting and no study drug will be provided. Enrolled participants will be followed prospectively over a 12-month study period, with interviews at baseline, 6 and 12 months. Sites will also abstract medical history and healthcare utilization information from the chart of each enrolled participant. There will be three chart abstractions (baseline, 6 Months, 12 Months). The baseline abstraction will cover services rendered in the 6 months prior to antipsychotic initiation or switch, or from their first visit to the CBHO if the individual did not receive services for as long as 6 months prior to initiation or switch. The 6M and 12M abstractions will each cover services rendered in the prior 6 months. When all three abstractions are complete, the data will cover the period from 6 months before baseline to 12 months after baseline. If a Serious Adverse Event (SAE) associated with a J\&J medicinal product occurs the investigator will record it in the source document as well as fax the SAE form to J\&J internal safety group within 24 hours. Treatment as usual
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Risperidone long acting injectable - New Starts, Risperidone long acting injectable - Continuous Users, Paliperidone Palmitate -New and Continuous Users, Other Antipsychotics - New Starts
- Keywords
- Risperidone long acting injectable, Risperdal Consta, Paliperidone Palmitate, Invega Sustenna
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone long acting injectable - New StartsDrug
Patients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort.
Risperidone long acting injectable - Continuous UsersDrug
Patients who have been on Risperidone long acting injectable for at least 6 months before baseline, with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort.
Paliperidone Palmitate -New and Continuous UsersDrug
Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
Other Antipsychotics - New StartsDrug
Participants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate
| Study group | Role | What they receive |
|---|---|---|
| 001 | Risperidone long acting injectable - New Starts Patients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort. Receives: Drug: Risperidone long acting injectable - New Starts | |
| 002 | Risperidone long acting injectable - Continuous Users Patients who have been on Risperidone long acting injectable for at least 6 months before baseline with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort. Receives: Drug: Risperidone long acting injectable - Continuous Users | |
| 003 | Paliperidone Palmitate -New and Continuous Users Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment Receives: Drug: Paliperidone Palmitate -New and Continuous Users | |
| 004 | Other Antipsychotics - New Starts Participants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate Receives: Drug: Other Antipsychotics - New Starts |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits.
Measured: Up to 12 months.
Secondary outcomes (5)
Demographic and related participant information
Measured: Baseline, 6 and 12 months
The Structured Clinical Interview for Symptoms of Remission (SCI-SR) will be used to assess remission among participants with schizophrenia.
Measured: Baseline, 6 and 12 months
Quality of life will be measured using a modified version of the brief version of Lehman's Quality of Life Interview (QOLI). Developed specifically for use with persons with serious mental illness, and assesses satisfaction.
Measured: Baseline, 6 and 12 months
Psychiatric clinical characteristics will include the age first hospitalized for schizophrenia or bipolar I disorder (as applicable), or the years since first diagnosis.
Measured: Baseline, 6 and 12 months
The Personal and Social Performance Scale (PSP) will be used to measure functioning in four key areas: socially useful activities, including work and study; personal and social relationships; self -care; and disturbing behaviors.
Measured: Baseline, 6 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 posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionNov 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,066 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181960
- Sponsor's protocol ID
- CR017107
- Other IDs
- RIS-OUT-239
- Status last verified
- Feb 2014
- First submitted
- 12 Aug 2010
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Joshi K, Mao L, Biondi DM, Millet R. The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia. BMC Psychiatry. 2018 Jan 29;18(1):24. doi: 10.1186/s12888-018-1594-1.
PubMed 29378547
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
- ClinicalTrials.gov ID
- NCT01181960
- Acronym / sponsor ID
- CR017107
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Risperidone long acting injectable, Risperdal Consta, Paliperidone Palmitate, Invega Sustenna
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,066 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Aug 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 purpose of this study is to build a data repository that can be used to understand pharmaceutical utilization patterns among patients being treated in community behavioral health organizations (CBHOs) for schizophrenia or bipolar I disorder.
Detailed description
This is a prospective observational study of usual care of patients undergoing treatment for schizophrenia or bipolar I disorder at CBHOs. Up to 50 CBHOs will be selected as sites for this study. Treating clinicians at these sites will notify the designated research coordinators for this study when they are initiating a patient on a new antipsychotic medication (including risperidone long acting injectable or paliperidone palmitate) or if they are treating a patient with risperidone long acting injectable or paliperidone palmitate. New initiation will include patients not previously on any antipsychotic medication as well as those switched from one antipsychotic to another. Switches may include but are not limited to switches among different types of oral antipsychotics, from an oral antipsychotic to Long Acting Therapy (LAT), or from LAT to an oral antipsychotic. Site research staff will screen potential participants identified by the clinicians and enroll those meeting study criteria who consent to study participation. Sites will maintain a screening log of all potential participants. The target enrollment for this study is up to 2,450 participants. Enrollment by cohort will be monitored and sites will be notified to stop enrollment if target enrollment for a particular cohort has been reached. Eligible participants who consent to the study will be recruited into one of two samples: participants with a schizophrenia diagnosis (target n=2,250) and participants with a bipolar I disorder diagnosis (target n=200). There will be four cohorts: risperidone long acting injectable new starts (target n=475); risperidone long acting injectable continuous users (target n=75); paliperidone palmitate new starts or continuous users (target n=1,200); and other antipsychotic new starts (target n=700). During the entire study follow-up period participants will receive their medication per usual care in their treatment setting and no study drug will be provided. Enrolled participants will be followed prospectively over a 12-month study period, with interviews at baseline, 6 and 12 months. Sites will also abstract medical history and healthcare utilization information from the chart of each enrolled participant. There will be three chart abstractions (baseline, 6 Months, 12 Months). The baseline abstraction will cover services rendered in the 6 months prior to antipsychotic initiation or switch, or from their first visit to the CBHO if the individual did not receive services for as long as 6 months prior to initiation or switch. The 6M and 12M abstractions will each cover services rendered in the prior 6 months. When all three abstractions are complete, the data will cover the period from 6 months before baseline to 12 months after baseline. If a Serious Adverse Event (SAE) associated with a J\&J medicinal product occurs the investigator will record it in the source document as well as fax the SAE form to J\&J internal safety group within 24 hours. Treatment as usual
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Risperidone long acting injectable - New StartsRisperidone long acting injectable - New Starts Patients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort. |
| 002 | – | Drug: Risperidone long acting injectable - Continuous UsersRisperidone long acting injectable - Continuous Users Patients who have been on Risperidone long acting injectable for at least 6 months before baseline with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort. |
| 003 | – | Drug: Paliperidone Palmitate -New and Continuous UsersPaliperidone Palmitate -New and Continuous Users Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment |
| 004 | – | Drug: Other Antipsychotics - New StartsOther Antipsychotics - New Starts Participants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Potential participants will be identified by treating clinicians at the site. The study will enroll participants treated at participating sites for schizophrenia and bipolar I disorder. The study does not involve administration of a study drug, but will naturalistically follow partticipants in these medication cohorts at the time of enrollment: clinician ordered initiation or switch to LAT within past 4 weeks, clinician ordered initiation or switch to oral antipsychotic within past 4 weeks, continuous users ( greater than or equal to 6 months) of Risperdal long acting injectable, continuous users (greater than or equal to 1 month) of Invega Sustenna.
Key inclusion criteria (10 listed)
- Diagnosed with schizophrenia or bipolar I disorder
- Antipsychotic use in one of the following categories: Clinician ordered initiation of Risperidone long acting injectable in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- On continuous Risperidone long acting injectable for at least 6 months prior to enrollment (no gaps between injections>30 days)
- Clinician ordered initiation of Paliperidone Palmitate in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
- or on continuous Paliperidone Palmitate for any time period prior to enrollment
Key exclusion criteria (1 listed)
- Currently participating in a clinical study (e.g. clinical trial or observational study) or participated in a clinical study within the past 30 days
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 |
|---|---|---|
| Risperidone long acting injectable - New StartsPatients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort. | Drug | 001 |
| Risperidone long acting injectable - Continuous UsersPatients who have been on Risperidone long acting injectable for at least 6 months before baseline, with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort. | Drug | 002 |
| Paliperidone Palmitate -New and Continuous UsersPatients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment | Drug | 003 |
| Other Antipsychotics - New StartsParticipants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate | Drug | 004 |
Primary outcome
The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits.
Time frame: Up to 12 months.
5 secondary outcomes
Demographic and related participant information
Time frame: Baseline, 6 and 12 months
The Structured Clinical Interview for Symptoms of Remission (SCI-SR) will be used to assess remission among participants with schizophrenia.
Time frame: Baseline, 6 and 12 months
Quality of life will be measured using a modified version of the brief version of Lehman's Quality of Life Interview (QOLI). Developed specifically for use with persons with serious mental illness, and assesses satisfaction.
Time frame: Baseline, 6 and 12 months
Psychiatric clinical characteristics will include the age first hospitalized for schizophrenia or bipolar I disorder (as applicable), or the years since first diagnosis.
Time frame: Baseline, 6 and 12 months
The Personal and Social Performance Scale (PSP) will be used to measure functioning in four key areas: socially useful activities, including work and study; personal and social relationships; self -care; and disturbing behaviors.
Time frame: Baseline, 6 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 12 Feb 2014.
- Derived from this study: PubMed 29378547Joshi K, Mao L, Biondi DM, Millet R. The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia. BMC Psychiatry. 2018 Jan 29;18(1):24. doi: 10.1186/s12888-018-1594-1.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by Janssen Scientific Affairs, LLC at 34 sites 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 10 inclusion and 1 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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.
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?
The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits. (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 NCT01181960, 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 12 Feb 2014.