Critical trial-related criteria in acute schizophrenia studies

European Archives of Psychiatry and Clinical Neuroscience

Volumn 262, Issue 2, 2012, Pages 151-155

  Riedel, Michael ^a,b   Leucht, Stefan ^c   Rüther, Eckart ^d   Schmaub, Max ^e   Möller, Hans Jürgen ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b Vinzenz von Paul Hospital   (Germany)

^c TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^d UNIVERSITY OF GÖTTINGEN   (Germany)

^e District Hospital Augsburg   (Germany)

Author keywords

Clinical trial; Schizophrenia; Withdrawal criteria

Indexed keywords

NEUROLEPTIC AGENT;

ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL (TOPIC); DIAGNOSTIC PROCEDURE; HUMAN; LEGAL ASPECT; MEDICAL ETHICS; MENTAL PATIENT; PATIENT SAFETY; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; QUALITY CONTROL; RATING SCALE; SCHIZOPHRENIA; SUICIDE; TREATMENT RESPONSE;

ACUTE DISEASE; CLINICAL TRIALS AS TOPIC; HUMANS; PLACEBOS; RESEARCH DESIGN; SCHIZOPHRENIA;

EID: 84863004193     PISSN: 09401334     EISSN: 14338491     Source Type: Journal    
DOI: 10.1007/s00406-011-0225-3     Document Type: Article

References (20)

1. Moller HJ, Maier W (2010) Evidence-based medicine in psychopharmacotherapy: possibilities, problems and limitations. Eur Arch Psychiatry Clin Neurosci 260 (1):25-39
2. Moller HJ, Broich K (2010) Principle standards and problems regarding proof of efficacy in clinical psychopharmacology. Eur Arch Psychiatry Clin Neurosci 260 (1):3-16
3. Melamed Y, Davidson M, Bleich A (2004) Placebo-controlled trials in schizophrenia. Harefuah 143 (3):236-40, 244
4. Helmchen H (2010) Ethical guidelines in psychiatric research. Eur Arch Psychiatry Clin Neurosci 260 (Suppl 2):S142-S146 (Epub;%2010 Oct 12.S142-S146)
5. Zipursky RB, Darby P (1999) Placebo-controlled studies in schizophrenia-ethical and scientific perspectives: an overview of conference proceedings. Schizophr Res 35 (3):189-200 (Pubitemid 29112970)
6. Stroup TS, Geddes JR (2008) Randomized controlled trials for schizophrenia: study designs targeted to distinct goals. Schizophr Bull 34 (2):266-274 (Pubitemid 351323336)
7. Depp C, Lebowitz BD (2007) Clinical trials: bridging the gap between efficacy and effectiveness. Int Rev Psychiatry 19 (5):531-539 (Pubitemid 47493737)
8. Carpenter WT Jr, Schooler NR, Kane JM (1997) The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 54 (5):401-407 (Pubitemid 27198203)
9. Meyer RE, Salzman C, Youngstrom EA, Clayton PJ, Goodwin FK, Mann JJ, Alphs LD, Broich K, Goodman WK, Greden JF, Meltzer HY, Normand SL, Posner K, Shaffer D, Oquendo MA, Stanley B, Trivedi MH, Turecki G, Beasley CM Jr, Beautrais AL, Bridge JA, Brown GK, Revicki DA, Ryan ND, Sheehan DV (2010) Suicidality and risk of suicide-definition, drug safety concerns, and a necessary target for drug development: a consensus statement. J Clin Psychiatry 71 (8):e1-e21
10. Moller HJ (2009) Standardised rating scales in psychiatry: methodological basis, their possibilities and limitations and descriptions of important rating scales. World J Biol Psychiatry 10 (1):6-26
11. Levine SZ, Rabinowitz J, Engel R, Etschel E, Leucht S (2008) Extrapolation between measures of symptom severity and change: an examination of the PANSS and CGI. Schizophr Res 98 (1-3):318-322 (Pubitemid 350235891)
12. Kay SR, Opler LA, Lindenmayer JP (1988) Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatry Res 23 (1):99-110
13. Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR (2005) What does the PANSS mean? Schizophr Res 79 (2-3): 231-238 (Pubitemid 41457263)
14. Carpenter WT Jr, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ, Kovnick J, Appelbaum PS (2000) Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 57 (6):533-538 (Pubitemid 30349432)
15. Agid O, Kapur S, Arenovich T, Zipursky RB (2003) Delayedonset hypothesis of antipsychotic action: a hypothesis tested and rejected. Arch Gen Psychiatry 60 (12):1228-1235 (Pubitemid 37494076)
16. Leucht S, Busch R, Hamann J, Kissling W, Kane JM (2005) Early-onset hypothesis of antipsychotic drug action: a hypothesis tested, confirmed and extended. Biol Psychiatry 57 (12):1543-1549 (Pubitemid 40805384)
17. Crespo-Facorro B, Pelayo-Teran JM, Perez-Iglesias R, Ramirez- Bonilla M, Martinez-Garcia O, Pardo-Garcia G, Vazquez-Barquero JL (2007) Predictors of acute treatment response in patients with a first episode of non-affective psychosis: sociodemographics, premorbid and clinical variables. J Psychiatr Res 41 (8): 659-666 (Pubitemid 46509645)
18. Emsley R, Rabinowitz J, Medori R (2006) Time course for antipsychotic treatment response in first-episode schizophrenia. Am J Psychiatry 163 (4):743-745 (Pubitemid 44464590)
19. Falkai P, Wobrock T, Lieberman J, Glenthoj B, Gattaz WF, Moller HJ (2005) World federation of societies of biological psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, Part 1: acute treatment of schizophrenia. World J Biol Psychiatry 6 (3):132-191
20. The European agency for the evaluation of medicinal products (2009) Note for guidance on the clinical investigation of medical products in the treatment of schizophrenia. http://www.eudra.org/emea.html