Qualitative methods in early-phase drug trials : data and methods from a trial of N-acetylcysteine in schizophrenia

Berk, Michael, Munib, Ahmed, Dean, Olivia, Malhi, Gin S., Kohlmann, Kristy, Schapkaitz, Ian, Jeavons, Sue, Katz, Fiona, Anderson-Hunt, Murray, Conus, Philippe, Hanna, Barbara, Otmar, Renée, Ng, Felicity, Copolov, David L. and Bush, Ashley I. 2011, Qualitative methods in early-phase drug trials : data and methods from a trial of N-acetylcysteine in schizophrenia, Journal of clinical psychiatry, vol. 72, no. 7, pp. 909-913, doi: 10.4088/JCP.09m05741yel.

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Title Qualitative methods in early-phase drug trials : data and methods from a trial of N-acetylcysteine in schizophrenia
Author(s) Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Munib, Ahmed
Dean, OliviaORCID iD for Dean, Olivia orcid.org/0000-0002-2776-3935
Malhi, Gin S.
Kohlmann, Kristy
Schapkaitz, Ian
Jeavons, Sue
Katz, Fiona
Anderson-Hunt, Murray
Conus, Philippe
Hanna, Barbara
Otmar, Renée
Ng, Felicity
Copolov, David L.
Bush, Ashley I.
Journal name Journal of clinical psychiatry
Volume number 72
Issue number 7
Start page 909
End page 913
Total pages 5
Publisher Physicians Postgraduate Press
Place of publication [Memphis, Tenn.]
Publication date 2011-07
ISSN 0160-6689
Keyword(s) acetylcysteine
data collection
double-blind method
free radical scavengers
middle aged
psychiatric status rating scales
schizophrenic psychology
Summary Objective: The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials.

Method: We undertook qualitative data analysis of clinical observations on the dataset of a randomized, double-blind, placebo-controlled trial of N-acetylcysteine (NAC) in patients with DSM-IV-TR–diagnosed schizophrenia (N = 140). Textual data on all participants, deliberately collected for this purpose, were coded using NVivo 2, and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005.

Results: The principal findings of the published trial could be replicated using a qualitative methodology. In addition, significant differences between NAC- and placebo-treated participants emerged for positive and affective symptoms, which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder.

Conclusions: The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research.
Language eng
DOI 10.4088/JCP.09m05741yel
Field of Research 119999 Medical and Health Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2010, Physicians Postgraduate Press
Persistent URL http://hdl.handle.net/10536/DRO/DU:30035463

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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