Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

NCT01181960 | Completed

• 2 other identifiers: CR017107RIS-OUT-239
• Study Type: observational
• Target: 1,066
• Locations: 1 country
• Sites: 34

Brief 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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Risperidone long acting injectable; Risperdal Consta; Paliperidone Palmitate; Invega Sustenna

Outcome Measures

Primary Outcomes (1)

• The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits.

  Up to 12 months.

Secondary Outcomes (5)

• Demographic and related participant information

  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.

  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.

  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.

  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.

  Baseline, 6 and 12 months

Study Arms (4)

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.

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.

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

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

Drug: Other Antipsychotics - New Starts

Interventions

Risperidone long acting injectable - New Starts DRUG

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.

001

Risperidone long acting injectable - Continuous Users DRUG

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.

002

Paliperidone Palmitate -New and Continuous Users DRUG

Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment

003

Other Antipsychotics - New Starts DRUG

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

004

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• Currently participating in a clinical study (e.g. clinical trial or observational study) or participated in a clinical study within the past 30 days

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (34)

Neuropsychiatry Clinic and Research Center

Bullhead City, Arizona, 86442, United States

Location

Shanti Clinical Trials

Colton, California, 92324, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

South Coast Clinical Trials, Inc.

Norwalk, California, 90650, United States

Location

Aurora Mental Health Center

Aurora, Colorado, 80014, United States

Location

LifeStream Behavioral Center, Inc.

Leesburg, Florida, 34749, United States

Location

APF Research

Miami, Florida, 33165, United States

Location

River Edge Behavioral Health Center

Macon, Georgia, 31217, United States

Location

Human Service Center (Fayette Companies)

Peoria, Illinois, 61603, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Centerstone-Indiana Centerstone Research Institute

Bloomington, Indiana, 47401, United States

Location

Medical Development Centers LLC (Baton Rouge)

Baton Rouge, Louisiana, 70808, United States

Location

Medical Development Centers LLC (Opelousas)

Opelousas, Louisiana, 70570, United States

Location

OCCMHA/Community Network Services, Inc.: Oakland County Community Mental Health Authority

Farmington Hills, Michigan, 48331, United States

Location

Cherry Street Health Services

Grand Rapids, Michigan, 49503, United States

Location

Bootheel Counseling Services

Sikeston, Missouri, 63801, United States

Location

Burrell Behavioral Health

Springfield, Missouri, 65804, United States

Location

CenterPointe Institute of Research

St Louis, Missouri, 63128, United States

Location

Premier Psychiatric Research Institute

Lincoln, Nebraska, 68526, United States

Location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03101, United States

Location

Bergen Regional Medical Center

Paramus, New Jersey, 07652, United States

Location

St Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Carolina Behavioral Care - Durham [CAREMARK]

Durham, North Carolina, 27705, United States

Location

Carolina Behavioral Care - Henderson

Henderson, North Carolina, 27536, United States

Location

Carolina Behavioral Care - Hillsborough

Hillsborough, North Carolina, 27278, United States

Location

Lehigh Valley Hospital Dept. of Psychiatry

Allentown, Pennsylvania, 18103, United States

Location

Family Services of Western Pennsylvania

Pittsburgh, Pennsylvania, 15238, United States

Location

Chestnut Ridge Counseling Services, Inc.

Uniontown, Pennsylvania, 15401, United States

Location

South Shore Mental Health Center

Charleston, Rhode Island, 02813, United States

Location

Human Service Center (Fayette Companies)

Pawtucket, Rhode Island, 61603, United States

Location

Centerstone-Tennessee Centerstone Research Institute

Nashville, Tennessee, 37228, United States

Location

Institute for Health Evaluation and Research Unlimited [IHEARU]

Arlington, Texas, 76016, United States

Location

Center for Health Care Services

San Antonio, Texas, 78229, United States

Location

Frontier Institute-Research Department for Spokane Mental Health

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 29378547 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

US (34)