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

Publication ,  Journal Article
Marder, SR; Alphs, L; Anghelescu, I-G; Arango, C; Barnes, TRE; Caers, I; Daniel, DG; Dunayevich, E; Fleischhacker, WW; Garibaldi, G; Green, MF ...
Published in: Schizophr Res
November 2013

A number of pharmacological agents for treating negative symptoms in schizophrenia are currently in development. Unresolved questions regarding the design of clinical trials in this area were discussed at an international meeting in Florence, Italy in April 2012. Participants included representatives from academia, the pharmaceutical industry, and the European Medicines Agency (EMA). Prior to the meeting, participants submitted key questions for debate and discussion. Responses to the questions guided the discussion during the meeting. The group reached agreement on a number of issues: (1) study subjects should be under the age of 65; (2) subjects should be excluded for symptoms of depression that do not overlap with negative symptoms; (3) functional measures should not be required as a co-primary in negative symptom trials; (4) information from informants should be included for ratings when available; (5) Phase 2 negative symptom trials should be 12weeks and 26weeks is preferred for Phase 3 trials; (6) prior to entry into a negative symptom study, subjects should demonstrate clinical stability for a period of 4 to 6months by collection of retrospective information; and (7) prior to entry, the stability of negative and positive symptoms should be confirmed prospectively for four weeks or longer. The participants could not reach agreement on whether predominant or prominent negative symptoms should be required for study subjects.

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Published In

Schizophr Res

DOI

EISSN

1573-2509

Publication Date

November 2013

Volume

150

Issue

2-3

Start / End Page

328 / 333

Location

Netherlands

Related Subject Headings

  • Schizophrenia
  • Psychiatry
  • Male
  • Humans
  • Female
  • Clinical Trials as Topic
  • Antipsychotic Agents
  • Aged, 80 and over
  • Aged
  • 3202 Clinical sciences
 

Citation

APA
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Marder, S. R., Alphs, L., Anghelescu, I.-G., Arango, C., Barnes, T. R. E., Caers, I., … Rabinowitz, J. (2013). Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. Schizophr Res, 150(2–3), 328–333. https://doi.org/10.1016/j.schres.2013.07.058
Marder, Stephen R., Larry Alphs, Ion-George Anghelescu, Celso Arango, Thomas R. E. Barnes, Ivo Caers, David G. Daniel, et al. “Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia.Schizophr Res 150, no. 2–3 (November 2013): 328–33. https://doi.org/10.1016/j.schres.2013.07.058.
Marder SR, Alphs L, Anghelescu I-G, Arango C, Barnes TRE, Caers I, et al. Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. Schizophr Res. 2013 Nov;150(2–3):328–33.
Marder, Stephen R., et al. “Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia.Schizophr Res, vol. 150, no. 2–3, Nov. 2013, pp. 328–33. Pubmed, doi:10.1016/j.schres.2013.07.058.
Marder SR, Alphs L, Anghelescu I-G, Arango C, Barnes TRE, Caers I, Daniel DG, Dunayevich E, Fleischhacker WW, Garibaldi G, Green MF, Harvey PD, Kahn RS, Kane JM, Keefe RSE, Kinon B, Leucht S, Lindenmayer J-P, Malhotra AK, Stauffer V, Umbricht D, Wesnes K, Kapur S, Rabinowitz J. Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. Schizophr Res. 2013 Nov;150(2–3):328–333.
Journal cover image

Published In

Schizophr Res

DOI

EISSN

1573-2509

Publication Date

November 2013

Volume

150

Issue

2-3

Start / End Page

328 / 333

Location

Netherlands

Related Subject Headings

  • Schizophrenia
  • Psychiatry
  • Male
  • Humans
  • Female
  • Clinical Trials as Topic
  • Antipsychotic Agents
  • Aged, 80 and over
  • Aged
  • 3202 Clinical sciences