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

January 21, 2019 updated by: Janssen Scientific Affairs, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Bullhead City, Arizona, United States
    • California
      • Oceanside, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • Florida
      • Lauderdale Lakes, Florida, United States
      • Leesburg, Florida, United States
      • Miami, Florida, United States
      • Orange City, Florida, United States
      • Tallahassee, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Granite City, Illinois, United States
      • Lombard, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Lawrenceburg, Indiana, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Mount Pleasant, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • New York
      • New York, New York, United States
      • Staten Island, New York, United States
    • Ohio
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
    • Rhode Island
      • Lincoln, Rhode Island, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Fort Worth, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Richland, Washington, United States
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other: Caregiver support available at the study site
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Month 12
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.
12 months
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.
12 months
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.
Month 6 and Month 12
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).
Month 12
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.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Scientific Affairs, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR106399
  • R092670SCH4043 (Other Identifier: Janssen Scientific Affairs)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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