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Cognitive–behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial

Haukeland University Hospital, Helse Bergen HF, Bergen

Stein Atle Lie and Holger Ursin

Research Centre for Health Promotion, Faculty of Psychology, University of Bergen, Bergen

Hege R. Eriksen

Department of Education and Health Promotion & Research Centre for Health Promotion, University of Bergen, Bergen, Norway

Correspondence: Dr Bjarte Stubhaug, Division of Psychiatry, Haukeland University Hospital, N-5021 Bergen, Norway. Email: bjarte.stubhaug{at}helse-bergen.no

Declaration of interest

The trial received an unrestricted grant from Organon AS, who provided the placebo-controlled medication.

Background

Single interventions in chronic fatigue syndrome have shown only limited effectiveness, with few studies of comprehensive treatment programmes.

Aims

To examine the effect of a comprehensive cognitive–behavioural treatment (CCBT) programme compared with placebo-controlled mirtazapine medication in patients with chronic fatigue, and to study the effect of combined medication and CCBT.

Method

A three-armed randomised clinical trial of mirtazapine, placebo and a CCBT programme was conducted to investigate treatment effect in a patient group (n=72) with chronic fatigue referred to a specialist clinic. The CCBT programme was compared with mirtazapine or placebo therapy for 12 weeks, followed by 12 weeks treatment with a mixed crossover–combination design. Assessments were done at 12 weeks and 24 weeks.

Results

By 12 weeks the treatment effect was significantly better in the group initially receiving CCBT, as assessed with the Fatigue Scale (P=0.014) and the Clinical Global Impression Scale (P=0.001). By 24 weeks the treatment group initially receiving CCBT for 12 weeks followed by mirtazapine for 12 weeks showed significant improvement compared with the other treatment groups on the Fatigue Scale (P<0.001) and the Clinical Global Impression Scale (P=0.002). Secondary outcome measures showed overall improvement with no significant difference between treatment groups.

Conclusions

Multimodal interventions may have positive treatment effects in chronic fatigue syndrome. Sequence of interventions seem to be of importance.