Ecological momentary assessment as a measurement tool in depression trials.

We used ecological momentary assessment (EMA) to track symptoms during a clinical trial. Thirty-six participants with major depressive disorder (MDD) and MADRS scores ≥20 were enrolled in a nonrandomized 6-week open-label trial of commercially available antidepressants. Twice daily, a mobile device prompted participants to self-report the 6 items of the HamD6 sub-scale derived from the Hamilton rating scale for depression (HamD17). Morning EMA reports asked "how do you feel now" whereas evening reports gathered a full-day impression. Clinicians who were blinded to the EMA data rated the MADRS, HamD17 and HamD6 at screen, baseline and weeks 2,4, and 6. Hierarchical linear modeling (HLM) examined the course of the EMA assessments and convergence between EMA scores and clinician ratings. HLM analyses revealed strong correlations between AM and PM EMA derived HamD6 scores and revealed significant improvements over time. EMA improvements were significantly correlated with the clinician rated HamD6 scores at endpoint and predicted clinician rated HamD6 score changes from baseline to endpoint (p < .001). There was a large correlation between EMA and clinician derived HamD6 scores at each in-person assessment after baseline. Treatment response defined by EMA matched the clinician rated HamD6 treatment responses in 33 of 36 cases (91.7%). EMA derived symptom scores appear to be efficient and valid measures to track daily symptomatic change in clinical trials and may provide more accurate measures of symptom severity than the episodic "snapshots" that are currently used as clinical outcomes. These findings support further investigation of EMA for assessment in clinical trials.

Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

OBJECTIVE: To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials. PARTICIPANTS: Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting. EVIDENCE: Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting. CONSENSUS PROCESS: Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded. CONCLUSIONS: All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions.

Strategies for maximizing clinical effectiveness in the treatment of schizophrenia.

The ultimate clinical objective in the treatment of schizophrenia is to enable affected individuals to lead maximally productive and personally meaningful lives. As with other chronic diseases that lack a definitive cure, the individual's service/recovery plan must include treatment interventions directed towards decreasing manifestations of the illness, rehabilitative services directed towards enhancing adaptive skills, and social support mobilization aimed at optimizing function and quality of life. In this review, we provide a conceptual framework for considering approaches for maximizing the effectiveness of the array of treatments and other services towards promoting recovery of persons with schizophrenia. We discuss pharmacological, psychological, and social strategies that decrease the burden of the disease of schizophrenia on affected individuals and their families while adding the least possible burden of treatment. In view of the multitude of treatments necessary to optimize outcomes for individuals with schizophrenia, effective coordination of these services is essential. In addition to providing best possible clinical assessment and pharmacological treatment, the psychiatrist must function as an effective leader of the treatment team. To do so, however, the psychiatrist must be knowledgeable about the range of available services, must have skills in clinical-administrative leadership, and must accept the responsibility of coordinating the planning and delivery of this multidimensional array of treatments and services. Finally, the effectiveness of providing optimal individualized treatment/rehabilitation is best gauged by measuring progress on multiple effectiveness domains. Approaches for efficient and reliable assessment are discussed.

Culture and assessment of manic symptoms.

Cultural background may influence the perception of psychiatric symptoms. We examined the effects of cultural biases on the identification of manic symptoms using the Young Mania Rating Scale. Two video interviews, each with an American person with mania, were shown to psychiatrists from three countries (US, UK and India). Total scores on the scale differed significantly between the US and UK (P<0.001) and between India and UK (P<0.001) rater groups. Overall, differences between India and US rater groups were less marked (P=0.28). These differences suggest that cultural biases influence the interpretation of manic symptoms.

Defining and measuring clinical effectiveness in the treatment of schizophrenia.

OBJECTIVES: Expectations in treating schizophrenia are expanding beyond just controlling psychotic symptoms to include functional recovery. This report describes an approach to define and measure the clinical effectiveness of treatment in achieving these objectives. METHODS: A comprehensive literature review established that there is limited information about the meaning of the term "clinical effectiveness." To address this gap a consensus conference of schizophrenia researchers was held to consider the components of clinical effectiveness in real-world community practice and how these components can best be measured. RESULTS: The consensus of the researchers was that effective clinical treatment is characterized by four outcome domains: symptoms of disease, treatment burden, disease burden, and health and wellness. A clinical instrument to measure these four domains was constructed: Global Outcome Assessment of Life in Schizophrenia (GOALS). In using GOALS, clinicians rate each of the four domains on a scale of 1, very much improved, to 7, very much worse. Field-testing of this instrument is planned. CONCLUSIONS: Effective treatment interventions that combine optimal pharmacotherapy and targeted psychosocial treatments are raising expectations about the prospects of functional recovery among patients with schizophrenia. GOALS is proposed as one tool that can provide busy clinicians with a simple, objective measure of the effectiveness and outcomes of the clinical treatment they provide to patients with schizophrenia.