Clinical Trial Design Challenges in Mood Disorders.

Front Cover -- Clinical Trial Design Challenges in Mood Disorders -- Copyright Page -- Contents -- List of Contributors -- Preface -- 1 Clinical Trial Design of Maintenance Treatments in Bipolar Disorder -- Introduction -- Design of Maintenance Treatment Trials in Bipolar Disorder -- Need for a Uniform Nomenclature of Course and Outcome in Bipolar Disorders -- Trial Duration -- Definition of Outcome -- Placebo-Controlled Maintenance Studies in Bipolar Disorder -- Patient Recruitment -- Course of Illness -- Symptoms Ratings -- Statistical Considerations -- Regulatory Considerations -- Conclusions -- References -- 2 Meta-Analysis of Clinical Trials in Bipolar Disorder -- Introduction -- Reduction of Risk of Suicide With Lithium: An Example of Increased Statistical Power by Pooling -- Publication Bias -- Individual Patient Data Meta-Analyses -- Multiple Treatments Meta-Analysis -- Conclusions -- References -- 3 Effectiveness Trials in Bipolar Disorders -- Efficacy Versus Effectiveness: Two Words With the Same But Different Meanings -- General Considerations -- Systematic Treatment Enhancement Program for Bipolar Disorder -- Bipolar Affective Disorder: Lithium/Anticonvulsant Evaluation Trial -- Danish University Antidepressant Group Study 6 -- Lithium Moderate Dose Use Study -- Bipolar Clinical Health Outcomes Initiative in Comparative Effectiveness Trial -- Conclusions -- References -- 4 Long-Term Treatment of Mood Disorders: Follow-Up of Acute Treatment Phase Studies Versus Continuation and Maintenance ... -- Introduction -- Requirements for Licensing Drugs in Mood Disorders -- Long-Term Follow-Up of Randomized (Placebo-)Controlled Acute Treatment Studies -- Randomized (Placebo-)Controlled Continuation Phase Withdrawal Studies -- Randomized (Placebo-)Controlled Maintenance Phase Withdrawal Studies -- Enriched Versus Nonenriched Designs.

Conclusion -- References -- 5 The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials -- Introduction -- Trials for Drug Registration Versus Trials that are Most Clinically Informative -- Why Superiority Designs are Preferred by Regulators in the Field of Bipolar Disorder -- The Need of Clinically Informative Designs: Alternatives to Superiority Observational and Exploratory Trials -- Noninferiority Designs -- Conclusions -- References -- 6 The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials -- Introduction -- A Rationale for Mixed-Method Approaches to Clinical Trial Design -- Qualitative Research Defined -- Theoretical Perspectives in Qualitative Research -- Ethnography -- Phenomenology -- Postmodernism -- Hermeneutics -- Middle-Range Theories -- Mixed Methods Research Defined -- Using Qualitative Methodologies in Clinical Trials -- Research Strategy -- Research Methods -- Sampling and Analysis -- Other Materials and Methods -- An Example: N-Acetylcysteine in Schizophrenia -- Benefits and Limitations in Using Mixed Methods in Clinical Trials -- Conclusion -- Conflicts of Interest Statement -- References -- 7 Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials -- Introduction -- SMART Methodologies -- SMART Study of Primary Lithium or Valproate in Clinically Symptomatic Bipolar Disorder Coupled with Second-Phase Randomizat ... -- Synopsis of the 26-Week, Open, Randomized SMART Bipolar Disorder Study -- Participants -- Study Summary -- Induction Phase -- Maintenance Phase -- Disposition of Subjects and Sample Size of Groups -- Medications -- Assessments -- Criteria for Recovered Status -- Hypothesis: A.2.1 -- Hypothesis A.3.1 -- Hypothesis A.2.2 -- Hypothesis A.2.3 -- Exploratory Analyses and Qualitative Aim 1 -- Power Analyses.

Innovation and Significance -- Approach and Feasibility -- Consideration in Planning and Executing SMART Protocols -- Selective Review of SMART Studies in Other Areas of Medicine -- Prospective Design Considerations for SMART Studies -- Matching the Statistical Analysis to the Rationale for a SMART -- References -- 8 Novel Study Designs for Clinical Trials in Mood Disorders -- Introduction -- Overcoming the Problem of Excessive Placebo Responses -- Standardizing Diagnostic Procedures -- Restricting Enrollment to Selected Populations -- Managing Clinicians' Overestimation of Change -- Rater Training -- Requirement of Same Rater -- Simplification of Study Visits and Assessments -- Minimizing Nonspecific, Therapeutic Effects -- Placebo Lead-in Phases -- Extending Trial Duration -- Reducing Number of Sites -- Increasing the Sensitivity of Outcome Measures -- Reducing the Number of Treatment Arms -- Standard Parallel Comparison Design -- Single-Blind Placebo Washout -- Crossover Design -- Adaptive Designs -- Randomized Play-the-Winner Clinical Trials -- Progressive Elimination of High Placebo Response Sites -- Sequential, Parallel Comparison Design -- An Example of Sequential, Parallel Comparison Design: L-Methylfolate as Adjunctive Therapy for Selective Serotonin Reuptake ... -- Trial One -- Trial Two -- Pooled Response Rates -- Conclusions -- Dr. Maurizio Fava's Lifetime Disclosures -- References -- 9 Rating Scales in Bipolar Disorder -- Introduction -- Screening Instruments for Bipolar Disorder -- General Behavioral Inventory -- Manic Depressiveness Scale -- Mood Disorder Questionnaire -- Bipolar Affective Disorder Dimensional Scale -- Bipolar Spectrum Diagnostic Scale -- Screening Assessment of Depression-Polarity -- Mania Scales -- Review of Instruments -- Description of Specific Instruments -- Rater-Administered Mania Scales.

Manic State Rating Scale -- Modified Manic Rating Scale -- Petterson Scale -- Young Mania Rating Scale -- Bech-Rafaelsen Scale -- Mania Rating Scale -- Mania Diagnostic and Severity Scale -- Clinician Administered Rating Scale for Mania -- Clinical Global Impression-Bipolar -- Patient-Rated Mania Scales -- Visual Analog Scales -- M-D Scale -- Self-Report Mania Inventory -- Affective Self-Rating Scale -- Altman Self-Report Mania Rating Scale -- Mania Scales in Clinical Trials and Related Literature -- Depression Scales in Bipolar Disorder -- Review of Instruments -- Description of Specific Instruments for Measuring Depressive Symptoms in Bipolar Disorder -- Rater-Administered Depression Scales Used in Bipolar Studies -- Hamilton Rating Scale for Depression -- Montgomery Äsberg Depression Rating Scale -- Inventory of Depressive Symptomatology -- Bipolar Depression Rating Scale -- Patient-Rated Depression Scales Used in Bipolar Studies -- Quick Inventory of Depressive Symptomatology -- Beck Depression Inventory -- Depression Scales in Clinical Trials and Related Literature -- Other Relevant Dimensions of Bipolar Outcome in Clinical Trials -- Bipolar Response using Rating Scales -- Bipolar Remission using Rating Scales -- Bipolar Relapse, Recurrence, and Recovery using Rating Scales -- Rating Scales to Assess Other Important Dimensions of Clinical Outcome among Bipolar Patients in Clinical Trials -- Rating Scales in Bipolar Populations Across the Lifespan -- Older Individuals with Bipolar Disorder -- Children with Bipolar Disorder -- Future Directions in Applications of Rating Scales in Bipolar Clinical Trials -- References -- 10 Clinical Applicability of Results from Drug Trials in Bipolar Disorder - An Attempt to Shed Light on a Complex Issue -- Introducing the Problem -- Aims and Methods -- Conceptual Framework -- Unfolding the Basic Concepts.

Selection of Subjects to Randomized Clinical Trials -- Narrow Versus Broad Generalizability -- Effect Size and Clinical Applicability of Trial Results -- Generalizability Across Classification Systems -- Generalizability Across Age -- Generalizability Across Drugs -- Generalizability and Adverse Effects -- Industry-Driven Versus Investigator-Driven Trials in General -- Generalizability and Clinical Applicability of Trial Results in Bipolar Disorder -- Mania -- Bipolar Depression -- Mixed States -- Maintenance -- Differential Generalizability or Trial Results Based on Biologic Subgroups in Bipolar Disorder -- Summarizing and Concluding Sections -- Proper Clinical Applicability of Trial Results in Bipolar Disorder: A Brief Guidance -- From Narrow Generalizability to Broad Applicability: Summarizing the Clinician's Point of View -- Approval Trials, Clinical Needs, and Future Perspectives -- References -- 11 Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation -- Introduction -- Clinical Trials in Developing Countries: Who Gains, and Why? -- Clinical Trials in Developing Countries: Who Loses, and Why? -- The Regulatory Environment -- Special Issues -- Discussion: Developments in India -- Concluding Notes -- References -- Index.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.