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

Stephen R. Marder, Larry Alphs, Ion George Anghelescu, Celso Arango, Thomas R E Barnes, Ivo Caers, David G. Daniel, Eduardo Dunayevich, W. Wolfgang Fleischhacker, George Garibaldi, Michael F. Green, Philip D Harvey, René S. Kahn, John M. Kane, Richard S E Keefe, Bruce Kinon, Stefan Leucht, Jean Pierre Lindenmayer, Anil K. Malhotra, Virginia Stauffer & 4 others Daniel Umbricht, Keith Wesnes, Shitij Kapur, Jonathan Rabinowitz

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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 12. weeks and 26. weeks 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 6. months 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.

Original languageEnglish
Pages (from-to)328-333
Number of pages6
JournalSchizophrenia Research
Volume150
Issue number2-3
DOIs
StatePublished - Nov 1 2013

Fingerprint

Drug Industry
Italy
Schizophrenia
Clinical Trials
Pharmacology
Depression

Keywords

  • Apathy
  • Negative symptoms
  • Schizophrenia

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

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. Schizophrenia Research, 150(2-3), 328-333. https://doi.org/10.1016/j.schres.2013.07.058

Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. / Marder, Stephen R.; Alphs, Larry; Anghelescu, Ion George; Arango, Celso; Barnes, Thomas R E; Caers, Ivo; Daniel, David G.; Dunayevich, Eduardo; Fleischhacker, W. Wolfgang; Garibaldi, George; Green, Michael F.; Harvey, Philip D; Kahn, René S.; Kane, John M.; Keefe, Richard S E; Kinon, Bruce; Leucht, Stefan; Lindenmayer, Jean Pierre; Malhotra, Anil K.; Stauffer, Virginia; Umbricht, Daniel; Wesnes, Keith; Kapur, Shitij; Rabinowitz, Jonathan.

In: Schizophrenia Research, Vol. 150, No. 2-3, 01.11.2013, p. 328-333.

Research output: Contribution to journalArticle

Marder, SR, Alphs, L, Anghelescu, IG, 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, JP, Malhotra, AK, Stauffer, V, Umbricht, D, Wesnes, K, Kapur, S & Rabinowitz, J 2013, 'Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia', Schizophrenia Research, vol. 150, no. 2-3, pp. 328-333. https://doi.org/10.1016/j.schres.2013.07.058
Marder SR, Alphs L, Anghelescu IG, Arango C, Barnes TRE, Caers I et al. Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. Schizophrenia Research. 2013 Nov 1;150(2-3):328-333. https://doi.org/10.1016/j.schres.2013.07.058
Marder, Stephen R. ; Alphs, Larry ; Anghelescu, Ion George ; Arango, Celso ; Barnes, Thomas R E ; Caers, Ivo ; Daniel, David G. ; Dunayevich, Eduardo ; Fleischhacker, W. Wolfgang ; Garibaldi, George ; Green, Michael F. ; Harvey, Philip D ; Kahn, René S. ; Kane, John M. ; Keefe, Richard S E ; Kinon, Bruce ; Leucht, Stefan ; Lindenmayer, Jean Pierre ; Malhotra, Anil K. ; Stauffer, Virginia ; Umbricht, Daniel ; Wesnes, Keith ; Kapur, Shitij ; Rabinowitz, Jonathan. / Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia. In: Schizophrenia Research. 2013 ; Vol. 150, No. 2-3. pp. 328-333.
@article{7af2431f0f80459a82db3a56afe6b01e,
title = "Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia",
abstract = "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 12. weeks and 26. weeks 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 6. months 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.",
keywords = "Apathy, Negative symptoms, Schizophrenia",
author = "Marder, {Stephen R.} and Larry Alphs and Anghelescu, {Ion George} and Celso Arango and Barnes, {Thomas R E} and Ivo Caers and Daniel, {David G.} and Eduardo Dunayevich and Fleischhacker, {W. Wolfgang} and George Garibaldi and Green, {Michael F.} and Harvey, {Philip D} and Kahn, {Ren{\'e} S.} and Kane, {John M.} and Keefe, {Richard S E} and Bruce Kinon and Stefan Leucht and Lindenmayer, {Jean Pierre} and Malhotra, {Anil K.} and Virginia Stauffer and Daniel Umbricht and Keith Wesnes and Shitij Kapur and Jonathan Rabinowitz",
year = "2013",
month = "11",
day = "1",
doi = "10.1016/j.schres.2013.07.058",
language = "English",
volume = "150",
pages = "328--333",
journal = "Schizophrenia Research",
issn = "0920-9964",
publisher = "Elsevier",
number = "2-3",

}

TY - JOUR

T1 - Issues and perspectives in designing clinical trials for negative symptoms in schizophrenia

AU - Marder, Stephen R.

AU - Alphs, Larry

AU - Anghelescu, Ion George

AU - Arango, Celso

AU - Barnes, Thomas R E

AU - Caers, Ivo

AU - Daniel, David G.

AU - Dunayevich, Eduardo

AU - Fleischhacker, W. Wolfgang

AU - Garibaldi, George

AU - Green, Michael F.

AU - Harvey, Philip D

AU - Kahn, René S.

AU - Kane, John M.

AU - Keefe, Richard S E

AU - Kinon, Bruce

AU - Leucht, Stefan

AU - Lindenmayer, Jean Pierre

AU - Malhotra, Anil K.

AU - Stauffer, Virginia

AU - Umbricht, Daniel

AU - Wesnes, Keith

AU - Kapur, Shitij

AU - Rabinowitz, Jonathan

PY - 2013/11/1

Y1 - 2013/11/1

N2 - 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 12. weeks and 26. weeks 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 6. months 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.

AB - 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 12. weeks and 26. weeks 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 6. months 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.

KW - Apathy

KW - Negative symptoms

KW - Schizophrenia

UR - http://www.scopus.com/inward/record.url?scp=84886283569&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84886283569&partnerID=8YFLogxK

U2 - 10.1016/j.schres.2013.07.058

DO - 10.1016/j.schres.2013.07.058

M3 - Article

VL - 150

SP - 328

EP - 333

JO - Schizophrenia Research

JF - Schizophrenia Research

SN - 0920-9964

IS - 2-3

ER -