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Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia

Stephen R Marder1, Larry Alphs, Ion-George Anghelescu

  • 1Semel Institute for Neuroscience at UCLA, Los Angeles, CA, USA; VA Desert Pacific Mental Illness Research, Education, and Clinical Center, Los Angeles, CA, USA.

Schizophrenia Research
|September 14, 2013
PubMed

Insights

New guidelines for clinical trials of schizophrenia treatments were established. Key recommendations include patient age limits and trial duration, enhancing research for negative symptoms.

Area of Science:

  • Psychiatry
  • Clinical Pharmacology
  • Schizophrenia Research

Background:

  • Numerous pharmacological agents targeting negative symptoms of schizophrenia are under development.
  • Unresolved questions regarding clinical trial design for these agents were discussed at an international meeting.

Purpose of the Study:

  • To discuss and reach consensus on critical issues in the design of clinical trials for negative symptoms of schizophrenia.
  • To establish guidelines for future research and development of novel treatments.

Main Methods:

  • An international meeting was held in Florence, Italy, in April 2012.
  • Participants from academia, industry, and the European Medicines Agency (EMA) discussed pre-submitted key questions.
  • Consensus was reached on several key aspects of trial design.

Main Results:

  • Agreement was reached on patient selection criteria (age < 65, exclusion of overlapping depression symptoms, requirement for clinical stability 4-6 months retrospectively and 4 weeks prospectively).
  • Consensus was achieved on trial duration (12 weeks for Phase 2, 26 weeks preferred for Phase 3) and the inclusion of informant ratings.
  • Functional measures were agreed not to be co-primary endpoints in negative symptom trials.
  • Disagreement persisted regarding the requirement for predominant or prominent negative symptoms for study entry.

Conclusions:

  • The meeting established important consensus points for designing clinical trials targeting negative symptoms in schizophrenia.
  • These guidelines aim to improve the efficiency and validity of research in this challenging area.
  • Further research is needed to address areas of continued disagreement, such as symptom prominence criteria.
Keywords:
ApathyNegative symptomsSchizophrenia

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