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| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCH4043 | Other Identifier | Janssen Scientific Affairs |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver psycho-education and skills training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Failures Over 12 Months | Treatment failure is defined as any of the following:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at 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 |
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Inclusion Criteria:
A) Caregivers
B) Patients
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bullhead City | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35436231 | Derived | Mueser KT, Achtyes ED, Gogate J, Mancevski B, Kim E, Starr HL. Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study. JMIR Ment Health. 2022 Apr 15;9(4):e32492. doi: 10.2196/32492. |
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| Caregiver support available at the study site | Other | Caregivers will receive whatever caregiver support that is customarily available at the study site, if any. |
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| Paliperidone palmitate | Drug | Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician. |
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| Chlorpromazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Droperidol | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Fluphenazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Haloperidol | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Loxapine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Perphenazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Pimozide | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Prochlorperazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Thiothixene | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Thioridazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Trifluoperazine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Aripiprazole | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Asenapine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Clozapine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Iloperidone | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Olanzapine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Paliperidone | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Quetiapine | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Risperidone | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Ziprasidone | Drug | Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician. |
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| Number of Treatment Failures in Patients Taking Oral Antipsychotics | Treatment failure is defined as any of the following:
| 12 months |
| Number of Treatment Failures in Patients Taking Paliperidone Palmitate | Treatment failure is defined as any of the following:
| 12 months |
| Patient Recovery Based on Total Illness Management and Recovery (IMR) Score | 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 | 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 | 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 |
| Oceanside |
| California |
| United States |
| Denver | Colorado | United States |
| Farmington | Connecticut | United States |
| 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 |
| Atlanta | Georgia | United States |
| Granite City | Illinois | United States |
| Lombard | Illinois | United States |
| Springfield | Illinois | United States |
| Bloomington | Indiana | United States |
| Lawrenceburg | Indiana | United States |
| Ann Arbor | Michigan | United States |
| Grand Rapids | Michigan | United States |
| Mount Pleasant | Michigan | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| New York | New York | United States |
| Staten Island | New York | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Lincoln | Rhode Island | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Fort Worth | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Richland | Washington | United States |
| Spokane | Washington | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| D002746 | Chlorpromazine |
| D004329 | Droperidol |
| D005476 | Fluphenazine |
| D006220 | Haloperidol |
| D008152 | Loxapine |
| D010546 | Perphenazine |
| D010868 | Pimozide |
| D011346 | Prochlorperazine |
| D013888 | Thiothixene |
| D013881 | Thioridazine |
| D014268 | Trifluoperazine |
| D000068180 | Aripiprazole |
| C522667 | asenapine |
| D003024 | Clozapine |
| C081732 | iloperidone |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D003989 | Dibenzoxazepines |
| D013892 | Thioxanthenes |
| D014966 | Xanthenes |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D003984 | Dibenzazepines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D011744 | Pyrimidinones |
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