Research

More than 811 Cherry Health patients have gained access to cutting-edge treatments and therapies by participating in current research projects through the Cherry Health Research Department. We are honored to be a part of these research efforts to find better treatments for those who experience mental illness, helping them to live full and productive lives.

We are especially proud of the NIH-sponsored RAISE study (Recovery After An Initial Schizophrenia Episode) which has been hailed as a ‘Landmark study’ and garnered national attention through media outlets like: the New York Times, the Washington Post, USA Today, US News and World Report, the Huffington Post, CBS News, ABC News, PBS Newshour, Grand Rapids Press, Ann Arbor News and others. The main results of the study, published in the American Journal of Psychiatry in October, was named among the ‘Top Ten’ articles in psychiatry for 2015 by the New England Journal of Medicine Journal Watch. The study has prompted Congressional action to set aside 10% of the SAMHSA state block grants to support treatment teams targeting first episode psychosis using the RAISE model.  The first three such teams have been set up in Michigan, including one in Grand Rapids, and the program is set to expand to support adding up to three more teams. 

Prelapse

Comparing the effectiveness of injectable aripiprazole for first episode and early phase schizophrenia to treatment as usual in community settings (CH is a T.A.U. site); also has an optional MRI component that is pending IRB approval

The PRELAPSE study seeks to compare the health outcomes of subjects who receive once-monthly Abilify to the outcomes of subjects who receive treatment as usual in community care settings for those who have had less than five years of lifetime exposure to antipsychotic medication. It is hypothesized that patients who receive a long-acting injectable early in their treatment will have better outcomes. Subjects at our site are part of the community care setting. We do not change, alter, or intervene with their care in any way; instead we follow them along through their course of treatment and collect information about healthcare utilization, medications, income, etc. We are enrolling into 2 arms of the study – first episode cohort and an early onset cohort. First episode subjects have had one psychotic episode and less than one year of antipsychotic treatment. Early onset subjects have had more than one psychotic episode and/or have been treated with antipsychotic medications for over one year. Participants complete in person assessments every 6 months and complete phone questionnaires every 2 months in between their study visits. Since this is voluntary, participants can stop the study at any time for any reason. An additional optional & voluntary protocol will soon be available for new study enrollees to capture brain imaging via MRI at baseline, 12 months and 24 months. Participants are compensated for their time and participation in the study.

This study is now closed to enrollment.
We are continuing data collection for those already enrolled in the study.

GPC

A study which seeks to find genetic biomarkers for schizophrenia, schizoaffective, and bipolar disorders

The Genomic Psychiatry Cohort (GPC) study seeks to further the NIMH’s collection of blood samples which are being analyzed to help understand the underlying genes involved in schizophrenia, schizoaffective disorder, and bipolar disorder. Over 33,000 samples have been collected thus far at all sites. We are currently enrolling persons of African descent only as this cohort was under-represented in the first round of samples. Eligible participants are diagnosed with schizophrenia, schizoaffective disorder (any subtype), or bipolar disorder. This study is typically completed in one visit lasting about 2 hours. Subjects donate a small sample of blood which is sent to the Rutgers Repository in New Jersey, and then complete a research questionnaire and interview with a member of the research team. The questionnaire and interview include information about school and work history, diagnosis, illness symptoms, substance use, family history, and any other health problems. Since this study is voluntary, participants can stop the study at any time for any reason. Participants may also refuse to answer any questions that cause discomfort. Subjects are compensated for their time and participation in the study.

This study is OPEN to eligible participants.

BARS-LAI

Randomized long-acting injectable aripiprazole once monthly versus standard of care oral antipsychotics in patients with schizophrenia identified non-adherent by the Brief Adherence Rating Scale (BARS)

A study comparing long-acting injectable Abilify (aripiprazole) to standard of care (SOC) antipsychotics as treatment options for persons diagnosed with schizophrenia. We hypothesize that non-adherent patients receiving aripiprazole once-monthly will be more likely to respond over 3 months of treatment than those receiving SOC oral antipsychotics. The Brief Adherence Rating Scale (BARS) will be used to identify adherence or non-adherence to SOC oral antipsychotics. If a patient is deemed adherent to their SOC oral antipsychotic for 3 consecutive months, then they will be terminated from the study without being randomized. If a patient is deemed non-adherent to their SOC oral antipsychotic at any time, then they will be randomized to either begin taking once-monthly aripiprazole or continue on their SOC oral antipsychotic. Throughout the study, patients’ general health and psychological health will be assessed. Once-monthly aripiprazole injections will be provided free of charge if randomized to this group. Patients are also compensated for their time and participation at each visit. This study is voluntary.

This study is OPEN to eligible participants.

CLOCS

A double blinded study seeking to see if the use of Clozapine, as compared to Risperidone, will help patients with schizophrenia/schizoaffective reduce their use of cannabis. Symptoms and side effects will also be assessed.

The CLOCS study is a study looking to see if people who have a “dual diagnosis” of schizophrenia / schizoaffective disorder and cannabis abuse / dependence can reduce their current levels of cannabis use. To be eligible for this study subjects need have used cannabis on 8 or more days over the 28 days prior to randomization and have been stable on an antipsychotic medication for the past 4 weeks. They also need to be treated with an antipsychotic medication other than clozapine or risperidone at the time of study entry and be willing to be treated with either clozapine or risperidone. Subjects are then randomized into two groups, one receiving clozapine and the other receiving risperidone. Subjects that enroll in the study will need to visit HOTC once a week for the duration of the study, for 14 weeks, as only a 7 day supply of medication will be provided at each visit. A breathalyzer test, a urine drug screen and blood draws will be done at every visit. Three times throughout the study patients will be asked to complete neuropsychiatric computer testing, which is provided on site. To provide collateral information, a family member, friend, or treating provider will be contacted once monthly with the patient’s consent. Subjects are provided with all medications at no charge and are also compensated with a small amount of money for each visit in the form of a gift card (cash is paid for returning meds). This study is completely voluntary.

This study is now closed to enrollment.

RAISE

Comparing intensive early intervention for first break psychotic episodes to treatment as usual in community settings (CH is a T.A.U. site); also has an optional genetics component

The RAISE study compares intensive treatment interventions (med management, individual resiliency therapy, family psychoeducation and supported employment/education counseling) to treatment as usual in community care settings for those who have had a first break psychotic episode. Subjects at our site are part of the community care setting. We do not change, alter, or intervene with their care in any way, but rather just follow them along through their course of treatment. Participants had monthly phone assessments to see how they have been accessing treatment, as well as in person assessments done every 6 months. We are now in an extended phase of this study and participants are only assessed every 6 months via telemedicine. Since this is voluntary, participants can stop the study at any time for any reason. An additional optional & voluntary protocol was available for participants already enrolled in RAISE which collected subjects’ DNA so that scientists can work to identify genes and biomarkers that may be associated with early episode psychosis, the progress of disease, or response to treatment for psychosis. We expect another optional & voluntary sub-study to begin soon that will investigate smoking rates & habits in RAISE early episode psychosis patients as this population has a higher rate of tobacco use than the general population. Participants are compensated for their time and participation in the study.

This study is now closed to enrollment.
We are continuing data collection for those already enrolled in the study. Initial findings have been published in Psychiatric Services. 2015; 66(7): 680-690, Psychiatric Services. 2015; 66(7): 677-679, Psychiatric Services. 2015; 66(7): 753-756, Psychiatric Services. 2015; 66(7): 665, The American Journal of Psychiatry. 2015; 172(3): 237-248, The Journal of Clinical Psychiatry. 2015; 76(3): 240-246, Psychiatric Rehabilitation Journal. 2014; 37(4): 267-269, and JAMA Psychiatry. 2014; 71(12): 1350-63. Information about this study was also published in U.S. News and World Report. 2015, and USA Today. 2015.

Depression Study

Randomized trial measuring levels of depression comparing telephone support interventions compared to a control group with care as usual. Both groups are comprised of patient / “CarePartner” pairs.

Patients with a depression diagnosis are asked to sign a ‘consent to be contacted form’ in order to validate their willingness to speak with study administrators at the University of Michigan. An introductory letter signed by their physician describing the study and permitting opt-out is then sent to their address. If a patient does not opt-out within two weeks, study administrators call to perform pre-consent and screening. In order to qualify, a patient must have a current PHQ9 score greater than or equal to 10, speak fluent English, and have a touch-tone phone at their disposal. Eligible patients then identify potential “CarePartners” (a close friend or family member who does not live in the patient’s household) which are screened and one is chosen to pair with the patient. These patient / “CarePartner” pairs are then randomly assigned to either the intervention or control groups. A patient assigned to the intervention group receives weekly calls monitoring their symptoms and access to the program website. Their “CarePartner” receives printed information about depression self-management, eLearning support, email reports, automated alerts, and access to the program website. A patient assigned to the control group receives care as usual and their “CarePartner” receives only the printed information about depression self-management. Patients may not enroll in the depression study if they do not receive services at Cherry Health.

This study is now closed to enrollment.

ICRC

The Improving Care Reducing Costs Study focuses on improving disease management and relapse prevention for individuals diagnosed with schizophrenia/schizoaffective disorder through the use of mobile and web-based technologies. By improving disease management and relapse prevention, the program proposes to reduce ER visits and hospital days while providing better care, better health, and increased patient satisfaction.

Patients with schizophrenia/schizoaffective disorder/Psychosis NOS who are enrolled in the study will work with the “Technology Supports Coordinator” (AKA Mental Health/Health Technology Case Manager) to develop a patient- specific relapse prevention plan which will accompany technological health aids that can be used and freely accessed in the home and/or in the community. These technologies can be accessed 24/7 throughout the intervention period (6 months/patient) whenever the patient needs them, not subject to the limitations of regular clinic hours. The websites and apps are structured to be simple and easy to use; mindful of cognitive impairments commonly associated with schizophrenia diagnosis. During the study period, the Technology Supports Coordinator (Betsy VanKlompenberg) will structure the intervention to the needs and abilities of the individual patient, deciding which technology treatment components to use for each personalized relapse prevention plan. The four available technology-enabled treatment components are as follows:
1) Prescriber Decision Assistant (PDA): a web-based, prescriber decision support system that will be utilized by Prescribers in the program (Dr. Eric Achtyes) in choosing medications based on known evidence-based practices. The PDA facilitates prescriber-patient communication and will be used for all participants.
2) Daily Support website: a web-based program for patients (and their families if desired) that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions. If a patient does not have a home computer with broadband web access, a laptop with internet access will be provided to them.
3) Web based Cognitive Behavior Therapy Programs: one to address managing voices (10 sessions long) and the other for managing paranoia (7 sessions long) are made available to patients to utilize at their own pace on a home computer/laptop. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies.
4) Android mobile phone Apps/text messaging: 2 specialized apps have been designed to improve medication adherence, socialization, and coping with auditory hallucinations for patients diagnosed with schizophrenia. The system prompts health-promoting behaviors and self-utilization of CBT techniques to improve outcomes in real-time and in real-world settings. All patients will be provided with an Android smartphone with unlimited data. The Technology Supports Coordinator will instruct patients on appropriate usage of the apps and on basic functions of the smartphone (call/text/alarm reminders); patients will be encouraged to use the phone regularly to connect with the treatment team and to connect with social supports.

To be in the study, patients must enroll within 30 days of discharge following psychiatric hospitalization. The first 10 patients enrolled in the study made up our standard reference group that just came in for research assessments but they did not receive the technology relapse prevention program. The subjects are compensated for completing research assessments (prescriber and HTCM visits are not paid visits) and participation is voluntary.

This study is now closed to enrollment.
We are continuing data analysis for this study.

ARRIVE

Looks at safety & tolerability and psychiatric hospitalization rates before and during treatment with injectable Abilify in patients with schizophrenia

Abilify (aripiprazole) is an antipsychotic medication that can be used as a treatment option for schizophrenia. It has been available as oral pills. The ARRIVE study, sponsored by Otsuka pharmaceuticals, looked at how well this medication works to help manage people’s symptoms as a long-acting injectable formulation and consisted of three phases – A,B and C. Some people prefer long-acting injections because then they don’t have to try to remember to take a pill everyday and only have to come in to a clinic for a shot once a month instead. The study compared how participants did on 6 months of the study medication compared to the 6 months before they started taking the study medication (by reviewing their medical chart). If a patient had not already been taking Abilify orally before the start of the study, they would be switched to oral Abilify to make sure there were no adverse reactions to the medicine (Phase A). Abilify-tolerating subjects then began their monthly injections and study visits (Phase B). Throughout the study, patients’ general health and psychological health was assessed. Phase C was intended to be an optional extension phase during which the patient could continue on the injection until December 2013 or until aripiprazole IM depot became commercially available. Injectable Abilify became available mid-study so participants no longer had the option of entering Phase C. The study medication was provided to the participant free of charge during the study and they were compensated for their time spent coming in for study visits. The study was voluntary.

This study is now closed to enrollment.
Results have been published in Journal of Medical Economics. 2013; 16(7): 917-925.

REACHOUT

Observational study comparing 2nd gen. injectable antipsychotics to oral antipsychotic medication in patients with schizophrenia and bipolar 1 disorder

An observational study that compares second generation long acting antipsychotic injectable medication, Risperdal Consta or Invega Sustenna, to oral antipsychotic medication in patients with schizophrenia and bipolar 1 disorder. Patients are followed over a 12-month study period and come in for interviews every 6 months. Retrospective chart abstractions and clinician questionnaires are also done every 6 months. Patients can start or stop treatment with the medication and still be enrolled in the study. Since this is voluntary, participants can stop the study at any time for any reason. Participants are compensated for their time and participation in the study.

This study is now closed to enrollment.

SCRP

Studying smoking cessation in patients with schizophrenia in 13 week varenicline trial + CBT groups followed by 40 week randomized trial of varenicline or placebo + CBT groups to study relapse prevention

The SCRP study (smoking cessation relapse prevention) is a study looking to see if we can help people who have schizophrenia cut down and hopefully quit smoking. For those that are eligible for the study they will start to receive the medicine varenicline (Chantix) to take each day. This is an FDA approved “quit smoking” medicine. In addition to the medicine study participants will attend weekly CBT (cognitive behavioral therapy) support groups, where they will learn tips and tricks to help them quit smoking, get encouragement from the group leader and peers on how to quit smoking and problem solve barriers and solutions to situations that make it difficult to quit smoking. For those that are able to completely quit smoking for at least the last 2 weeks of the 13 week CBT program they will continue on with our relapse prevention phase of the study where we will try to help patients stay quit (those that weren’t able to completely quit during the first 13 weeks just end the study at week 13). For those that continue we want to know if they need to keep taking the medicine to stay quit or not. So half of the people will continue taking the medicine and half will start taking a placebo (or sugar pill) instead. They will be double-blinded which means that the study participant and the research staff won’t know whether the participant is taking the real medicine or the placebo (though we can find out in an emergency). But no matter what the study participant is taking they will all continue to come to support groups that will now be focused on relapse prevention. The groups will slowly be tapered off though, where you come in once a week, then every other week, then once a month for a total of 40 additional weeks. Also periodically (7 times over the course of the year) clients will come in for individual research visits where we will do lab work and many different assessments to see if there is any change in the person’s physical and psychological health during the study. Patients are also compensated with a small amount of money for each visit and group they attend as a thank you for helping us out with their study. This study is completely voluntary.

This study is now closed to enrollment.
We are continuing data analysis for this study, but the initial findings have been published in: JAMA. 2014; 311(2): 145-154, Journal of Dual Diagnosis. 2012; 8:2, 117-125, and Journal of Clinical Psychiatry, in press.

RADIAUS

Double blind pilot study to see if risperidone + desiprimine might mimic the mechanism of action of clozapine in the brain and reduce drinking in patients with schizophrenia. Symptoms and side effects will also be assessed.

The RADIAUS study is a study looking to see if people who have a “dual diagnosis” of schizophrenia / schizoaffective disorder and alcohol abuse / dependence can reduce their current drinking levels. To be eligible for this study subjects need to have drunk alcohol on at least 10 of the previous 30 days, of which 5 of those 10 days were “heavy drinking days” (≥5 drinks/day for men or ≥4 for women). Subjects already taking risperidone, paliperidone (Invega), paliperidone palmitate (injectable), or risperidone LA (injectable) will be allowed to stay on these medications for the duration of the study. Subjects not currently on any of these antipsychotics would need to be switched and titrated onto risperidone. No other antipsychotics may be taken during the study. Subjects are then randomized into two groups, one receiving risperidone and desiprimine, and the other receiving risperidone and placebo. Desiprimine is an antidepressant. No other antidepressants may be taken during the study. Subjects that enroll in the study will need to visit HOTC once a week for the duration of the study, for 17 weeks, as only an 8 day supply of medication will be provided at each visit. Drinking levels, a breathalyzer test, and a urine drug screen will be done at every visit. Blood draws will be performed at three different occasions throughout the study in order to monitor health. To provide collateral information, a family member or a friend will be contacted with the patient’s consent. Subjects are provided with all medications at no charge and are also compensated with a small amount of money for each visit in the form of a gift card (cash is paid for returning meds). This study is completely voluntary.

This study is now closed to enrollment.
We are continuing data analysis for this study.

ZEBRA

The Ziprasidone Escalation to Better Realize Antipsychotic Efficacy study compared the use of higher doses of ziprasidone to achieve improvement in symptom control of schizophrenia as compared to control groups using conventional dosing of ziprasidone.

This study is now closed to enrollment.
Results from this study have been published in Journal of Clinical Psychopharmacology. 2013; 33(4): 485-490.

Folate/B12

Examined the efficacy of folate and vitamin B12 supplementation to improve cognition and reduce negative symptoms of schizophrenia as compared to a placebo controlled group.

This study is now closed to enrollment.
Results from this study have been published in JAMA Psychiatry. 2013; 70(5): 481-489.


Conflict of Interest Policy Regarding Research Projects