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Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) (FIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02600741
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.

Condition or disease Intervention/treatment
Schizophrenia Other: Caregiver psycho-education and skills training Other: Caregiver support available at the study site Drug: Paliperidone palmitate Drug: Chlorpromazine Drug: Droperidol Drug: Fluphenazine Drug: Haloperidol Drug: Loxapine Drug: Perphenazine Drug: Pimozide Drug: Prochlorperazine Drug: Thiothixene Drug: Thioridazine Drug: Trifluoperazine Drug: Aripiprazole Drug: Asenapine Drug: Clozapine Drug: Iloperidone Drug: Olanzapine Drug: Paliperidone Drug: Quetiapine Drug: Risperidone Drug: Ziprasidone

Detailed Description:
This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment
Actual Study Start Date : July 24, 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Study group 1
Caregivers randomized to this group will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician.
Other: Caregiver psycho-education and skills training
Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
Drug: Paliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Drug: Chlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Droperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Fluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Haloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Loxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Perphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Pimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Prochlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Thiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Thioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Trifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Aripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Asenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Clozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Iloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Olanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Paliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Quetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Risperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Ziprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Study group 2
Caregivers randomized to this group will receive whatever caregiver support that is customarily available at the study site, if any. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician.
Other: Caregiver support available at the study site
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
Drug: Paliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Drug: Chlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Droperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Fluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Haloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Loxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Perphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Pimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Prochlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Thiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Thioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Trifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Aripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Asenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Clozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Iloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Olanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Paliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Quetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Risperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Drug: Ziprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.


Outcome Measures

Primary Outcome Measures :
  1. Number of Treatment Failures Over 12 Months [ Time Frame: 12 months ]

    Treatment failure is defined as any of the following:

    1. Psychiatric hospitalization
    2. Psychiatric emergency room (ER) visit
    3. Crisis center visit
    4. Mobile crisis unit intervention
    5. Arrest/Incarceration
    6. Suicide or suicide attempt.


Secondary Outcome Measures :
  1. Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12 [ Time Frame: Month 12 ]
    The IEQ is designed to measure levels of caregiver consequences among family members and friends of patients with schizophrenia. The 31 items included in this scale are answered on a 5 point Likert response scale and address consequences among 4 dimensions (tension, supervision, worrying, and urging).

  2. Number of Treatment Failures in Patients Taking Oral Antipsychotics [ Time Frame: 12 months ]

    Treatment failure is defined as any of the following:

    1. Psychiatric hospitalization
    2. Psychiatric emergency room (ER) visit
    3. Crisis center visit
    4. Mobile crisis unit intervention
    5. Arrest/Incarceration
    6. Suicide or suicide attempt.

  3. Number of Treatment Failures in Patients Taking Paliperidone Palmitate [ Time Frame: 12 months ]

    Treatment failure is defined as any of the following:

    1. Psychiatric hospitalization
    2. Psychiatric emergency room (ER) visit
    3. Crisis center visit
    4. Mobile crisis unit intervention
    5. Arrest/Incarceration
    6. Suicide or suicide attempt.

  4. Patient Recovery Based on Total Illness Management and Recovery (IMR) Score [ Time Frame: Month 6 and Month 12 ]
    The IMR program was developed in order to help patients with schizophrenia or major mood disorders learn how to manage their illnesses more effectively in the context of pursuing their personal goals.

  5. Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12 [ Time Frame: Month 12 ]
    The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) to 7 (amongst the most severely ill patients).

  6. Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12 [ Time Frame: Month 12 ]
    The 12-item Short Form Health Survey (SF-12) is a self-administered, generic, 12-item questionnaire designed to cover the same 8 domains of functional health status and well-being included in the longer 36-item Short Form Health Survey (SF 36): physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will consist of a paired patient and caregiver. A caregiver is defined as a person who has accepted responsibility for providing the patient with both assistance with activities of daily living and protection from harm. The patient will have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Criteria

Inclusion Criteria:

A) Caregivers

  • Each caregiver must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate for the duration of the study
  • Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report

B) Patients

  • Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
  • Patients must be receiving ongoing psychiatric treatment at the study site and must be receiving oral antipsychotics or paliperidone palmitate long acting therapy

Exclusion Criteria:

  • A) Caregivers
  • Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
  • Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
  • Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
  • Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
  • Patient is receiving assertive community treatment (ACT) or other high intensity case management services to prevent hospitalization
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600741


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Arizona
Neuropsychiatry Clinic and research center Completed
Bullhead City, Arizona, United States, 86442
United States, California
North County Clinical Research Completed
Oceanside, California, United States, 92056
Asclepes Research Withdrawn
Panorama City, California, United States, 91402
United States, Colorado
Mental Health Centers of Denver Completed
Denver, Colorado, United States, 80222
United States, Connecticut
UConn Health Center Completed
Farmington, Connecticut, United States, CT
United States, Florida
Henderson Behavioral Health Active, not recruiting
Lauderdale Lakes, Florida, United States, 33319
LifeStream Behavioral Center, Inc. Completed
Leesburg, Florida, United States, 34748
APG Research, LLC Withdrawn
Maitland, Florida, United States, 32803
Florida Medical Center & Research, Inc. Completed
Miami, Florida, United States, 33142
Research Centers of America, LLC Withdrawn
Oakland Park, Florida, United States, 33334
Medical Research Group of Central Florida Recruiting
Orange City, Florida, United States, 32763
Apalachee Center Inc. Active, not recruiting
Tallahassee, Florida, United States, 32308
Jerome Golden Center for Behavioral Health, Inc. Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Behavioral Research, LLC Recruiting
Atlanta, Georgia, United States, 30338
United States, Illinois
Chestnut Health Systems Recruiting
Granite City, Illinois, United States, 62040
Comprehensive Clinical Services, P.C. Completed
Lombard, Illinois, United States, 60148
Southern Illinois University School of Medicine Completed
Springfield, Illinois, United States, 62794-9642
United States, Indiana
Centerstone Research Institute Completed
Bloomington, Indiana, United States, 47403
Community Mental Health Center, Inc. Active, not recruiting
Lawrenceburg, Indiana, United States, 47025
United States, Louisiana
Louisiana State University Withdrawn
New Orleans, Louisiana, United States, 70115
United States, Michigan
Michigan Clinical Research Institute Completed
Ann Arbor, Michigan, United States, 48105
Heart of the City Health Center/ Cherry Health Active, not recruiting
Grand Rapids, Michigan, United States, 49503
CMH for Central Michigan Active, not recruiting
Mount Pleasant, Michigan, United States, 48858
United States, Missouri
Galen Research Withdrawn
Chesterfield, Missouri, United States, 63005
University of Missouri - Kansas City Active, not recruiting
Kansas City, Missouri, United States, 64108
Mid-America Clinical Research, LLC Recruiting
Saint Louis, Missouri, United States, 63109
United States, New Hampshire
Mental Health Center of Greater Manchester Withdrawn
Manchester, New Hampshire, United States, 3101
United States, New York
Fountain House Completed
New York, New York, United States, 10025-1716
Manhattan Psychiatric Center Completed
New York, New York, United States, 10027
Richmond Behavioural Associates Completed
Staten Island, New York, United States, 10312
United States, Ohio
Unison Behavorial Health Group Active, not recruiting
Toledo, Ohio, United States, 43623
United States, Oklahoma
Oklahoma Clinical Research Center Completed
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group Completed
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Peace Health Recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Translational Neuroscience, LLC Withdrawn
Conshohocken, Pennsylvania, United States, 19428
University of Pittsburgh Medical Center Withdrawn
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Lincoln Research Active, not recruiting
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Centerstone Research Institute Active, not recruiting
Nashville, Tennessee, United States, 37228
United States, Texas
BioBehavioral Research of Austin, PC Completed
Austin, Texas, United States, 78759
John Peter Smith Active, not recruiting
Fort Worth, Texas, United States, 76104
The Center for Health Care Services Active, not recruiting
San Antonio, Texas, United States, 78208
Focus & Balance Research LLC Completed
San Antonio, Texas, United States, 78229
United States, Utah
Psychiatric and Behavioral Solutions Active, not recruiting
Salt Lake City, Utah, United States, 84105-2425
United States, Washington
Zain Research LLC Completed
Richland, Washington, United States, 99352
Frontier Institute/Spokane Mental Health Completed
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Chair: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
More Information

Additional Information:
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02600741     History of Changes
Other Study ID Numbers: CR106399
R092670SCH4043 ( Other Identifier: Janssen Scientific Affairs )
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Janssen Scientific Affairs, LLC:
Schizophrenia
Caregiver
Psycho-education and skills training
Paliperidone Palmitate
Oral Antipsychotic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Paliperidone Palmitate
Ziprasidone
Clozapine
Antipsychotic Agents
Aripiprazole
Olanzapine
Quetiapine Fumarate
Haloperidol
Asenapine
Loxapine
Prochlorperazine
Droperidol
Chlorpromazine
Perphenazine
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Pimozide
Thioridazine
Trifluoperazine
Thiothixene
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs