Schizophrenia
Conditions
Keywords
Schizophrenia, Caregiver, Psycho-education and skills training, Paliperidone Palmitate, Oral Antipsychotic
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.
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.
Interventions
DRUGPaliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
OTHERCaregiver 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.
OTHERCaregiver support available at the study site
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
DRUGChlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGDroperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGFluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGHaloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGLoxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGPerphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGPimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGProchlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGThiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGThioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGTrifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGAripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGAsenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGClozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGIloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGOlanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGPaliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGQuetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGRisperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
DRUGZiprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Failures Over 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Failures in Patients Taking Oral Antipsychotics | 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 | 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. |
| Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12 | 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). |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12 | 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 | 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. |
| Patient Recovery Based on Total Illness Management and Recovery (IMR) Score | 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. |
Countries
United States
Outcome results
None listed