Cognitive training and modafinil for cognition in schizophrenia-V2

• Research type

  Research Study

• Full title

  A Pilot study of cognitive enhancer and cognitive training combination – Testing a therapeutic paradigm for cognitive impairment in schizophrenia

• IRAS ID

  42260

• Contact name

  Shitij Kapur

• Eudract number

  2009-013020-23

• ISRCTN Number

  ISRCTN60687844

• Research summary

  Schizophrenia is one of the most disabling psychiatric illnesses: it begins in adolescence and inflicts distress and disability for patient and family, while costing the UK more than œ10 billion in lost income and support. Even with the best treatments, only 15% of patients with schizophrenia find paid employment. A major cause of disability are the cognitive symptoms of schizophrenia, i.e. problems in memory, attention, concentration, planning ahead and managing social interactions, also called “cognitive impairments” The current treatments for schizophrenia, the antipsychotic medications, help with the psychotic symptoms (i.e. with the hallucinations and the paranoia) but are not effective for the treatment of cognitive symptoms. The focus of our study is to improve these cognitive symptoms with the hope that this would allow patients with schizophrenia to increase their everyday functioning. The strategies to improve cognitive symptoms in schizophrenia include pharmacological (based on modulation of brain chemistry), and non-pharmacological approaches (based on training interventions to improve cognitive abilities) and research has shown that both approaches can improve cognition modestly. We will combine these two approaches to study if their effects on cognitive symptoms of patients with schizophrenia can be boosted. Forty patients with schizophrenia in a stable clinical condition will be recruited, and will be randomly allocated to receive either modafinil (the pharmacological cognition enhancing agent) or an inactive compound and will undergo cognitive training sessions, during which they will complete attention, memory and learning tasks. We expect that the combination of modafinil with cognitive training will enhance the performance of patients and will last after the discontinuation of the training and modafinil. The duration of the study will be 5 weeks and will be conducted by trained researchers in 2 study sites, the Institute of Psychiatry, King's College London and University of Manchester.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/14

• Date of REC Opinion

  23 Mar 2010

• REC opinion

  Further Information Favourable Opinion