ACTIONS

Antidepressant controlled trial for negative symptoms in schizophrenia (ACTIONS): A double-blind, placebo-controlled, randomised clinical trial

The negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialization, speech, and movement. Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome of people with schizophrenia. There are currently no approved pharmacological treatments for negative symptoms. This study seeks to assess the potential benefit of a depression medication in this patient population. The DHE has been involved in the economic evaluation of this intervention alongside the ACTIONS study.

With regard to health economic measures, there were no statistically significant differences between the citalopram arm and the placebo arm but a considerably larger sample size may be needed to draw robust conclusions on the cost-effectiveness of the use of antidepressants in combination with antipsychotics to treat persistent negative symptoms in people with schizophrenia who do not fulfil the criteria for major depression. The current study highlights the importance of balancing the treatment arms at baseline in such trials according to usual accommodation (specifically, whether or not the patient is living in a psychiatric institution), collecting baseline cost information, and correcting for any imbalance in a respective health economic analysis.

Dates:
2013-2015

Funding:
UK NIHR HTA

Collaborator(s):
Centre for Mental Health, Imperial College London, UK

Information:
Judit Simon

Publication(s):
Barnes TRE, Leeson VC, Paton C, Costelloe C, Simon J, Kiss N, Osborn D, Killaspy H, Craig TKJ, Lewis S, Keown P, Ismail S, Crawford M, Baldwin D, Lewis G, Geddes J, Kumar M, Pathak R, Taylor S (2016) Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial. Health Technology Assessment, 20(29). DOI: 10.3310/hta20290.