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

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ClinicalTrials.gov Identifier: NCT02600741
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

September 29, 2015
November 9, 2015
July 2, 2018
July 24, 2015
June 30, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02600741 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Same as current
Not Provided
Not Provided
 
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Schizophrenia
  • 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.
  • 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.
  • 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.
    Interventions:
    • Other: Caregiver psycho-education and skills training
    • 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
  • 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.
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
310
300
June 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02600741
CR106399
R092670SCH4043 ( Other Identifier: Janssen Scientific Affairs )
No
Not Provided
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Not Provided
Study Chair: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
June 2018