RECOVERY- (RAISE) Recovery After Initial Schizophrenia Episode

This award is a multi-site clinical trial to design and test a method of intervention that has the capacity to promote engagement and adherence to treatment, foster recovery, and reduce or prevent disability in patients experiencing a first episode of schizophrenia and related psychotic disorders.

The period of performance is July 13, 2009, through July 12, 2011, with options to extend the contract to include a large randomized, controlled trial and to extend performance for enhanced data analysis. The total period of performance with options is until July 12, 2015.

This award was made under full and open competition, but it is not fixed price due to the uncertain costs of research and development contracts.

This is 1 (one) of 2 (two) awards under this RFP. In addition to this award, a second award was made to The Feinstein Institute for Medical Research.

The National Institute of Mental Health (NIMH) is seeking information on all sources capable of responding to a potential new solicitation entitled "Recovery After an Initial Schizophrenic Episode (RAISE)". The goal of this initiative will be to improve prognosis and long-term outcome for people suffering from schizophrenia.

Despite the development and widespread use of antipsychotic drugs, schizophrenia still devastates the lives of young adults and their families. Chronic deterioration and a lifetime of disability remain the norm. The bitter lesson from a half-century of treatment research has been that skills and abilities lost to chronic schizophrenia are rarely, if ever, regained. However, unlike chronically ill patients, people experiencing a first psychotic episode usually respond well to treatment, and many are able to completely recover. Treatment responsiveness changes over time, but in current practice, management of the first year of illness differs little from management of the twentieth year. The unanswered question is whether aggressive, integrated, and sustained pharmacological, psychosocial, and rehabilitative intervention after an initial schizophrenic episode can forestall chronic disability.



While the question is straightforward, finding an answer will not be simple. A large scale randomized clinical trial (RCT), costing many tens of millions of dollars will be required to definitively answer this question. Before undertaking such a large commitment, many unknowns need to be addressed, including the feasibility of recruiting and retaining newly diagnosed patients in a longitudinal trial; the treatment model, particularly which mix of pharmacological, psychological, and rehabilitative interventions has the best chance of both preventing deterioration and maintaining subject participation; the nature of the control intervention; and at least some pilot evidence that the intervention will be successful.



The purpose of RAISE is to

1. Determine the feasibility of an RCT testing whether chronic loss of function can be prevented after an initial episode of psychosis (not substance induced, affective disorder related, or related to a neurological or medical disorders)

2. Develop an intervention or service delivery system incorporating an adaptive model for individualized treatment to promote long term recovery after an initial psychotic episode. This will require input and on-going involvement from investigators studying pharmacological, psychosocial, and rehabilitative interventions in schizophrenia, particularly the first episode. This will also require substantive input and on-going involvement from clinicians, policy makers, advocates, and consumers familiar with consumer and family-driven mental health systems (as envisioned by the President's New Freedom Commission on Mental Health)

3. Define and develop a "treatment as usual" comparator (or service delivery system)

4. Test and refine the intervention and comparator, obtaining pilot data in a cohort of between 200 - 500 subjects recruited and followed over the course of the project from multiple sites representative of first episode patients in the community.

5. Disseminate results and promote awareness and interest in early intervention to prevent chronic deterioration in schizophrenia.

6. Stimulate research on illness course, as well as mediators and moderators of outcome in schizophrenia

7. If the pilot results from RAISE are promising, identify and cultivate potential funding sources outside of NIMH) that could fund (or co-fund) a large scale, definitive RCT



While a single source will be selected, NIMH anticipates that collaboration between multiple investigators and institutions will be required. The specific experience and capabilities necessary to perform this work include (but are not limited to):

1) Experience in performing randomized clinical trials in schizophrenia, particularly in first episode patients;

2) Ability to recruit significant numbers of subjects experiencing an initial psychotic episode from multiple representative community sites, and ability to retain and follow up subjects in an ongoing clinical trial

3) Experience with model mental health delivery systems, and familiarity with consumer and family driven, recovery focused systems (as envisioned by the President's New Freedom Commission on Mental Health)

4) The capability to develop a new adaptive treatment model involving pharmacological, psychosocial, and rehabilitative interventions to promote long term recovery and forestall loss of function in people in a first psychotic episode;

5) The capability to develop appropriate outcome measures and control conditions;

6) The ability to collect, analyze, and report multi-site pilot data from subjects with schizophrenia that could inform the design of a successor RCT;

7) Experience collaborating with multiple experts and stakeholders (investigators, clinicians, policy makers, advocates, and consumers) in schizophrenia research



Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5-10 pages, single-spaced), indicating previous experience and capabilities related to the above work. Capability Statements should clearly state/describe: 1) the offerors experience and qualifications to perform this work; 2) your type of business or organization, its size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable (Note: the applicable NAICS code for this requirement is 541712, 500 employees/revenue); and 3) your management structure, history of your organization (e.g., number of years in business and DUNS #); and 4) other resources available to perform this work (e.g. scientific equipment, laboratory facilities, etc.).