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Development of novel behavioral interventions in an experimental therapeutics world: Challenges, and directions for

Kathryn E Lewandowski¹, Dost Ongur¹, Matcheri S Keshavan²

¹McLean Hospital, Schizophrenia and Bipolar Disorder Program, 115 Mill St., Belmont, MA, USA; Harvard Medical School, Department of Psychiatry, 401 Park Drive, Boston, MA, USA.

Schizophrenia Research

|June 21, 2017

Abstract:

Recently, the focus of funding mechanisms associated with clinical trials has changed to be consistent with an experimental therapeutics approach. While this approach holds considerable promise, the paradigm shift has presented challenges for behavioral trials in complex psychiatric illness such as schizophrenia, as molecular targets - the classic focus in experimental therapeutics paradigms - may not represent logical targets for many psychosocial interventions designed to treat multifaceted, multiply determined symptoms. Clear guidelines for alternate models have not been offered, leaving large numbers of clinical trials researchers unclear about how to frame their work. We address some of the challenges for behavioral interventions research, and offer guidance for the development of novel approaches to the application of a target engagement framework to behavioral clinical trials.

Insights

Funding for clinical trials is shifting towards experimental therapeutics, posing challenges for behavioral interventions in psychiatric disorders like schizophrenia. New frameworks are needed to guide behavioral trials effectively.

Area of Science:

Psychiatry
Behavioral Science
Clinical Trials

Background:

Clinical trial funding is increasingly aligned with experimental therapeutics.
This shift challenges behavioral intervention research in complex psychiatric illnesses, such as schizophrenia.
Psychosocial interventions for multifaceted symptoms may not align with traditional molecular targets.

Purpose of the Study:

To address challenges in behavioral interventions research for psychiatric disorders.
To offer guidance for novel approaches in behavioral clinical trials.
To adapt the target engagement framework for behavioral interventions.

Main Methods:

Review of current funding trends in clinical trials.
Analysis of challenges for behavioral interventions in psychiatric research.
Development of a target engagement framework applicable to behavioral trials.

Main Results:

Identified misalignment between experimental therapeutics and behavioral interventions.
Highlighted the need for specific guidelines for behavioral clinical trials.
Proposed an adapted target engagement framework for behavioral interventions.

Conclusions:

The experimental therapeutics model presents unique challenges for behavioral research in psychiatry.
Clearer guidelines and novel frameworks are necessary for successful behavioral intervention trials.
Adapting the target engagement concept can provide a structured approach for behavioral clinical trials.

Read full analysis

Keywords:

Behavioral Clinical trial Experimental therapeutics Intervention Mechanism Target

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