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

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ClinicalTrials.gov Identifier: NCT02600741
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

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 Type : Observational
Actual Enrollment : 296 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
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 5, 2018

Resource links provided by the National Library of Medicine


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.




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.



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, Older Adult)
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

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


  Show 34 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Chair: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

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: September 24, 2018
Last Verified: September 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