Universität zu Köln

Schmidt, Stefanie J., Hurlemann, Rene ORCID: 0000-0003-2628-565X, Schultz, Johannes ORCID: 0000-0003-4117-232X, Wasserthal, Sven, Kloss, Christian, Maier, Wolfgang, Meyer-Lindenberg, Andreas, Hellmich, Martin, Muthesius-Digon, Ana, Pantel, Tanja, Wiesner, Pia-Sophie, Klosterkoetter, Joachim, Ruhrmann, Stephan ORCID: 0000-0002-6022-2364, Bechdolf, A., Brockhaus-Dumke, A., Hirjak, D., Fallgatter, A., Frieling, H., Janssen, B., Jessen, F., Kambeitz, J., Koutsouleris, N., Leopold, K., Schaefer, C., Schultze-Lutter, F., Striepens, N., Vernaleken, I, Walter, H. and Wildgruber, D. (2019). Multimodal prevention of first psychotic episode through N-acetyl-l-cysteine and integrated preventive psychological intervention in individuals clinically at high risk for psychosis: Protocol of a randomized, placebo-controlled, parallel-group trial. Early Interv. Psychiatry, 13 (6). S. 1404 - 1416. HOBOKEN: WILEY. ISSN 1751-7893

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Abstract

Aim Meta-analyses indicate positive effects of both antipsychotic and cognitive-behavioural interventions in subjects clinically at high risk (CHR) for psychosis in terms of a delay or prevention of psychotic disorders. However, these effects have been limited regarding social functioning and the relative efficacy of both types of interventions remains unclear. Furthermore, neuroprotective substances seem to be a promising alternative agent in psychosis-prevention as they are associated with few and weak side-effects. Methods In this multi-centre randomized controlled trial (RCT), we investigate the effects of two interventions on transition to psychosis and social functioning: (a) an integrated preventive psychological intervention (IPPI) including stress-/symptom-management and social-cognitive remediation; (b) N-acetyl-l-cysteine (NAC) as a pharmacological intervention with glutamatergic, neuroprotective and anti-inflammatory capabilities. Results This is a double-blind, placebo-controlled RCT with regard to NAC and a single-blind RCT with regard to IPPI using a 2 x 2-factorial design to investigate the individual and combined preventive effects of both interventions. To this aim, a total of 200 CHR subjects will be randomized stratified by site to one of four conditions: (a) IPPI and NAC; (b) IPPI and Placebo; (c) NAC and psychological stress management; (d) Placebo and psychological stress management. Interventions are delivered over 26 weeks with a follow-up period of 12 months. Conclusion This paper reports on the rationale and protocol of an indicated prevention trial to detect the most effective and tolerable interventions with regard to transition to psychosis as well as improvements in social functioning, and to evaluate the synergistic effects of these interventions.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schmidt, Stefanie J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hurlemann, Rene UNSPECIFIED orcid.org/0000-0003-2628-565X UNSPECIFIED Schultz, Johannes UNSPECIFIED orcid.org/0000-0003-4117-232X UNSPECIFIED Wasserthal, Sven UNSPECIFIED UNSPECIFIED UNSPECIFIED Kloss, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Maier, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Meyer-Lindenberg, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Muthesius-Digon, Ana UNSPECIFIED UNSPECIFIED UNSPECIFIED Pantel, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiesner, Pia-Sophie UNSPECIFIED UNSPECIFIED UNSPECIFIED Klosterkoetter, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruhrmann, Stephan UNSPECIFIED orcid.org/0000-0002-6022-2364 UNSPECIFIED Bechdolf, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brockhaus-Dumke, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hirjak, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fallgatter, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Frieling, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Janssen, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jessen, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kambeitz, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Koutsouleris, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Leopold, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaefer, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schultze-Lutter, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Striepens, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vernaleken, I UNSPECIFIED UNSPECIFIED UNSPECIFIED Walter, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wildgruber, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-126523
DOI:	10.1111/eip.12781
Journal or Publication Title:	Early Interv. Psychiatry
Volume:	13
Number:	6
Page Range:	S. 1404 - 1416
Date:	2019
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1751-7893
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ULTRA-HIGH RISK; SOCIAL COGNITION; PSYCHOMETRIC PROPERTIES; GLUTATHIONE PRECURSOR; COMMUNITY SAMPLE; RATING-SCALE; EPA GUIDANCE; AT-RISK; SCHIZOPHRENIA; VALIDATION Multiple languages Psychiatry Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/12652