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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 主要终点
- Number of Treatment Failures Over 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Caregiver psycho-education and skills training (Other)
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.
干预措施: Paliperidone palmitate (Drug)
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.
干预措施: Chlorpromazine (Drug)
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.
干预措施: Droperidol (Drug)
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.
干预措施: Fluphenazine (Drug)
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.
干预措施: Haloperidol (Drug)
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.
干预措施: Loxapine (Drug)
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.
干预措施: Perphenazine (Drug)
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.
干预措施: Pimozide (Drug)
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.
干预措施: Prochlorperazine (Drug)
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.
干预措施: Thiothixene (Drug)
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.
干预措施: Thioridazine (Drug)
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.
干预措施: Fluphenazine (Drug)
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.
干预措施: Trifluoperazine (Drug)
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.
干预措施: Aripiprazole (Drug)
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.
干预措施: Asenapine (Drug)
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.
干预措施: Clozapine (Drug)
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.
干预措施: Iloperidone (Drug)
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.
干预措施: Olanzapine (Drug)
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.
干预措施: Paliperidone (Drug)
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.
干预措施: Quetiapine (Drug)
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.
干预措施: Risperidone (Drug)
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.
干预措施: Ziprasidone (Drug)
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.
干预措施: Caregiver support available at the study site (Other)
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.
干预措施: Paliperidone palmitate (Drug)
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.
干预措施: Chlorpromazine (Drug)
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.
干预措施: Droperidol (Drug)
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.
干预措施: Haloperidol (Drug)
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.
干预措施: Loxapine (Drug)
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.
干预措施: Perphenazine (Drug)
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.
干预措施: Pimozide (Drug)
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.
干预措施: Prochlorperazine (Drug)
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.
干预措施: Thiothixene (Drug)
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.
干预措施: Thioridazine (Drug)
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.
干预措施: Trifluoperazine (Drug)
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.
干预措施: Aripiprazole (Drug)
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.
干预措施: Asenapine (Drug)
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.
干预措施: Clozapine (Drug)
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.
干预措施: Iloperidone (Drug)
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.
干预措施: Olanzapine (Drug)
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.
干预措施: Paliperidone (Drug)
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.
干预措施: Quetiapine (Drug)
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.
干预措施: Risperidone (Drug)
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.
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Number of Treatment Failures Over 12 Months
时间窗: 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.
次要结局
- Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12(Month 12)
- Number of Treatment Failures in Patients Taking Oral Antipsychotics(12 months)
- Number of Treatment Failures in Patients Taking Paliperidone Palmitate(12 months)
- Patient Recovery Based on Total Illness Management and Recovery (IMR) Score(Month 6 and Month 12)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12(Month 12)
- Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12(Month 12)