Effective September 2020, the Schizophrenia Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 26, 2021 for the first review cycle, up to June 25, 2021 for the second review cycle, and up to September 17, 2021 for the third review cycle. This is a competitive process that will be conducted by the Schizophrenia MISP in 2021. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below.
The following areas are of interest to the Investigator Studies Program Committee:
Schizophrenia or Bipolar Mixed/Mania Patient Populations
- Methods for predicting treatment response and relapse
- Factors that either increase or decrease adherence to treatment with antipsychotic medication, and the effects of increasing adherence on relapse, outcome, and economic costs in schizophrenia/bipolar
- Relationship of symptom improvement to functional outcomes, including meaningful measurements of quality of life.
Disruptive Behavioral Symptoms of Dementia (such as aggression, agitation, impulsivity, psychosis)
- Methods for assessing changes in severity of disruptive behavioral symptoms in various settings (such as home, assisted living, or long-term care) and across severity of dementia.
- Methods for assessing the impact on caregivers of disruptive behavioral symptoms in various settings (such as home, assisted living, or long-term care) and across severity of dementia.
- Methods for assessing the relationship between disruptive behavioral symptoms and other measures of function in various settings (such as home, assisted living, or long-term care) and across severity of dementia.
Effects of antipsychotic-induced weight gain (and metabolic syndrome)
- Changes in treatment adherence due to antipsychotic-induced weight gain and metabolic syndrome
- Clinician-reported or patient-reported preferences in defining valued health outcomes.
- Relationship between co-morbid obesity / metabolic syndrome and subsequent outcomes in patients (excludes studies focused primarily on medication-related AE’s)
Mobile devices, wearables, and other remote sensing device/data technology
The utility of mobile devices, wearables, other remote sensing device and data collection technology for monitoring clinical change and treatment outcomes of patients with schizophrenia, bipolar mixed/mania, or disruptive behavioral symptoms of dementia.
Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the Schizophrenia MISP Committee.
Critical Activities and Timelines:
||1st Review Cycle
||2nd Review Cycle
||3rd Review Cycle
|Protocol Submission with Detailed Budget
||Mar 26, 2021
||June 25, 2021
||Sep 17, 2021
|Decision to Investigator
||Apr 16, 2021
||July 17, 2021
||Oct 8, 2021