Resistant Depression - Ketamine Infusion Trial Evaluation (RED-KITE)

• Research type

  Research Study

• Full title

  ReD-KITE: Resistant Depression - Ketamine Infusion Trial Evaluation: a phase I, dose escalation, safety study

• IRAS ID

  19136

• Contact name

  Rupert H McShane

• Sponsor organisation

  Oxfordshire and Buckinghamshire Mental Health NHS Foundation Trust

• Eudract number

  2009-016941-25

• ISRCTN Number

  n/a

• Research summary

  Depression is a condition affecting many people and for some the disorder can be resistant to standard antidepressant treatment. This can have a destructive impact on an individual??s personal and working life, and is associated with increased risks of self harm and suicide. There are currently limited options available to address treatment resistant depression. Alternate pharmacological and psychological approaches exist but vary in their effectiveness and availability. A common alternate treatment method, electro-convulsive therapy, can improve mood but may significantly affect memory and may be less acceptable to patients. There is a need to develop alternative treatment methods, which act quickly and produce sustainable effects with few side effects. Ketamine is a safe, cheap anaesthetic. A recent trial of a single very low dose ketamine showed a dramatic antidepressant effect lasting 1-2 days for most of the 18 patients, for 7 days in 35%, and for 18 days in 2 cases. Ketamine thus shows potential as an effective treatment method. However, before the potential benefit of ketamine can be explored, its safety, tolerability and side effects must be understood. Ketamine in higher doses can cause brief psychotic-like symptoms though not of a severity which prevent its very wide use as an anaesthetic. Little is known, however, about the effect of repeated ketamine doses on cognitive function. The proposed study will investigate the safety and effects of ketamine in individuals with treatment resistant depression. Twelve participants with treatment resistant depression will receive ketamine infusions once a week for three weeks in a hospital clinic. Participants will be regularly monitored for mood, memory and any side effects. If ketamine is shown to be tolerated, a second stage will take place and 12 participants will receive ketamine twice a week for three weeks with the same assessment schedule.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/118

• Date of REC Opinion

  16 Nov 2009

• REC opinion

  Favourable Opinion