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Randomized Controlled Trial
. 2010 Aug 19:341:c4024.
doi: 10.1136/bmj.c4024.

Maintenance treatment with quetiapine versus discontinuation after one year of treatment in patients with remitted first episode psychosis: randomised controlled trial

Eric Y H Chen  1 , Christy L M Hui, May M L Lam, Cindy P Y Chiu, C W Law, Dicky W S Chung, Steve Tso, Edwin P F Pang, K T Chan, Y C Wong, Flora Y M Mo, Kathy P M Chan, T J Yao, S F Hung, William G Honer
Affiliations
Randomized Controlled Trial

Maintenance treatment with quetiapine versus discontinuation after one year of treatment in patients with remitted first episode psychosis: randomised controlled trial

Eric Y H Chen et al. BMJ. .

Abstract

Objective: To study rates of relapse in remitted patients with first episode psychosis who either continued or discontinued antipsychotic drugs after at least one year of maintenance treatment.

Design: 12 month randomised, double blind, placebo controlled trial.

Setting: Early psychosis outpatient clinics in Hong Kong.

Participants: 178 patients with first episode psychosis who had received at least one year of antipsychotic drug treatment between September 2003 and July 2006 and had no positive symptoms of psychosis.

Interventions: Patients received either maintenance treatment with quetiapine (400 mg/day) or placebo and were followed up for the next 12 months or until a relapse occurred.

Main outcome measure: Relapse assessed monthly and defined as re-emergence of psychotic symptoms (delusions, conceptual disorganisation, hallucinations, suspiciousness, and unusual thought content) according to predefined thresholds.

Results: 178 patients were randomised (89 to quetiapine and 89 to placebo). The Kaplan-Meier estimate of the risk of relapse at 12 months was 41% (95% confidence interval 29% to 53%) for the quetiapine group and 79% (68% to 90%) for the placebo group (P<0.001). Although quetiapine was generally well tolerated, the rate of discontinuation due to adverse or serious adverse events was greater in the quetiapine group (18%; 16/89) than in the placebo group (8%; 7/89) (relative risk 2.29, 95% confidence interval 0.99 to 5.28; chi(2)=3.20, df=1; P=0.07).

Conclusion: In a group of asymptomatic patients with first episode psychosis and at least one year of previous antipsychotic drug treatment, maintenance treatment with quetiapine compared with placebo resulted in a substantially lower rate of relapse during the following year. Trial registration Clinical trials NCT00334035.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and all authors declare (1) Financial support for the submitted work from Research Grants Council of Hong Kong and AstraZeneca Pharmaceuticals. (2) EYHC has participated in paid advisory boards for Otsuka, has received educational grant support from Janssen-Cilag, and has received research funding from AstraZeneca, Janssen-Cilag, Pfizer, Eli Lilly, Sanofi-Aventis, and Otsuka; MMLL has done consultancy for Otsuka and Eli Lilly; DWSC has received research grants from Janssen-Cilag and Pfizer; WGH has participated in advisory boards for In-Silico Biosciences, Wyeth/Solvay, Janssen-Cilag, and AstraZeneca; has done consultancy for Novartis and AstraZeneca; and has received lecture fees from Janssen-Cilag, Pfizer, and AstraZeneca and educational grant support from Janssen-Cilag, Eli Lilly, and AstraZeneca; CLMH, CPYC, CWL, ST, EPFP, KTC, YCW, FYMM, KPMC, TJY, and SFH declare no relationships with commercial entities that might have an interest in the submitted work in the previous 3 years. All authors declare that they have (3) no spouses, partners, or children with financial relationships with commercial entities that may be relevant to the submitted work, and (4) no non-financial interests that may be relevant to the submitted work.

Figures

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Fig 1 Enrolment and outcomes. ITT=intention to treat
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Fig 2 Kaplan-Meier analysis in remitted first episode psychosis patients with and without antipsychotic maintenance treatment. Median duration of follow-up was 145 (interquartile range 41-351) days for quetiapine group and 106 (57-243) days for placebo group
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