Ketamine-ECT Study

• Research type

  Research Study

• Full title

  Ketamine augmentation of ECT to improve outcomes in depression

• IRAS ID

  79725

• Contact name

  Ian Anderson

• Sponsor organisation

  Manchester Mental Health and Social Care Trust

• Eudract number

  2011-005476-41

• ISRCTN Number

  ISRCTN14689382

• Research summary

  Depression is a major cause of disability with many patients failing to recover with current drug and psychological treatments. Electroconvulsive Therapy (ECT), the most effective treatment known for severe depression, can be life-saving but remains controversial. The most serious concern is impairment in memory and other cognitive (thinking) abilities which can lead to patients stopping ECT too soon and many people report distressing long-term loss of past memories. If these memory and cognitive effects could be prevented, and fewer ECT treatments were needed, this would represent an important advance and would change clinical practice. Ketamine is an anaesthetic drug that blocks the effects of the brain chemical, glutamate, involved in memory and mood. The proposed study will investigate the benefit of adding ketamine to the usual anaesthetic used for ECT by studying 160 patients due to receive ECT. Following giving informed consent they will be randomised to either receive ketamine injection or saline placebo during ECT. The effects of the treatment will be assessed using validated measures of memory, cognitive function and mood improvement during, at the end of and one and four months after treatment. We will also use brain imaging to investigate whether ketamine a) prevents the ECT-induced impaired working of the front part of the brain (frontal cortex) believed to contribute to cognitive adverse effects, and b) reduces disruption in connections between the frontal cortex and an important memory area of the brain (hippocampus). Given the difficulty in studying severely ill people we will use magnetic resonance imaging (MRI) in a small subgroup to look at the network connections and brain glutamate levels. We will relate this to results obtained in a majority of patients from a simple, portable, imaging technology, near infrared spectroscopy (NIRS).

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0021

• Date of REC Opinion

  25 Jan 2012

• REC opinion

  Favourable Opinion