PMID- 25227564 OWN - NLM STAT- MEDLINE DCOM- 20150728 LR - 20181202 IS - 1879-1379 (Electronic) IS - 0022-3956 (Linking) VI - 59 DP - 2014 Dec TI - L-lysine as an adjunct to risperidone in patients with chronic schizophrenia: a double-blind, placebo-controlled, randomized trial. PG - 125-31 LID - S0022-3956(14)00252-0 [pii] LID - 10.1016/j.jpsychires.2014.08.016 [doi] AB - Increasing evidence suggest that the nitric oxide signaling system of the brain may contribute to the pathophysiology of schizophrenia, making this system a target for development of novel therapeutics. The objective of this study was to investigate the efficacy and safety of L-lysine as an adjunctive to risperidone in the treatment of patients with chronic schizophrenia during an 8-week trial. Seventy-two chronic schizophrenia inpatients with a Positive and Negative Syndrome Scale (PANSS) total score of >/= 60 participated in a randomized, double-blind, placebo-controlled trial in the active phase of their disease and underwent 8 weeks of treatment with either L-lysine (6 g/day) or placebo as an adjunctive to risperidone. Patients were evaluated using PANSS and its subscales at baseline and weeks 2, 4, 6 and 8. The primary outcome measure was to evaluate the efficacy of L-lysine in improving schizophrenia symptoms. Repeated measures analysis demonstrated significant effect for time x treatment interaction on the PANSS total (P < 0.001), negative (P < 0.001) and general psychopathology (P < 0.001) subscale scores but not the PANSS positive subscale scores (P = 0.61). The frequency of adverse events (AEs) did not differ significantly between the two treatment groups and no serious AE was observed. The present study demonstrated that l-lysine can be a tolerable and efficacious adjunctive therapy for improving negative and general psychopathology symptoms in chronic schizophrenia. However, the safety and efficacy of higher doses of l-lysine and longer treatment periods still remain unknown. TRIAL REGISTRATION: Iranian registry of clinical trials (www.irct.ir): IRCT201202201556N33. CI - Copyright (c) 2014 Elsevier Ltd. All rights reserved. FAU - Zeinoddini, Atefeh AU - Zeinoddini A AD - Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. FAU - Ahadi, Morvarid AU - Ahadi M AD - Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. FAU - Farokhnia, Mehdi AU - Farokhnia M AD - Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. FAU - Rezaei, Farzin AU - Rezaei F AD - Department of Psychiatry, Kurdistan University of Medical Sciences, Sanandaj, Iran. FAU - Tabrizi, Mina AU - Tabrizi M AD - Department of Medical Genetics, Tehran University of Medical Sciences, Tehran, Iran. FAU - Akhondzadeh, Shahin AU - Akhondzadeh S AD - Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: s.akhond@neda.net. LA - eng SI - IRCT/IRCT201202201556N33 PT - Address PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140906 PL - England TA - J Psychiatr Res JT - Journal of psychiatric research JID - 0376331 RN - 0 (Antipsychotic Agents) RN - K3Z4F929H6 (Lysine) RN - L6UH7ZF8HC (Risperidone) SB - IM MH - Adult MH - Antipsychotic Agents/*therapeutic use MH - Chronic Disease MH - Depression/drug therapy/etiology MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Lysine/*therapeutic use MH - Male MH - Psychiatric Status Rating Scales MH - Risperidone/*therapeutic use MH - Schizophrenia/complications/*drug therapy MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Clinical trial OT - Nitric oxide OT - PANSS OT - Schizophrenia OT - l-lysine EDAT- 2014/09/18 06:00 MHDA- 2015/07/29 06:00 CRDT- 2014/09/18 06:00 PHST- 2014/05/06 00:00 [received] PHST- 2014/07/23 00:00 [revised] PHST- 2014/08/21 00:00 [accepted] PHST- 2014/09/18 06:00 [entrez] PHST- 2014/09/18 06:00 [pubmed] PHST- 2015/07/29 06:00 [medline] AID - S0022-3956(14)00252-0 [pii] AID - 10.1016/j.jpsychires.2014.08.016 [doi] PST - ppublish SO - J Psychiatr Res. 2014 Dec;59:125-31. doi: 10.1016/j.jpsychires.2014.08.016. Epub 2014 Sep 6.