The effects of Lu AA21004 on cognition and BOLD fMRI

• Research type

  Research Study

• Full title

  Interventional randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of Lu AA21004 on cognition and BOLD fMRI signals in subjects remitted from depression and controls

• IRAS ID

  97983

• Contact name

  Guy Goodwin

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2011-001839-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to determine if Lu AA21004 20 mg/day over 13 to 14 days, compared to placebo, will lead to changes in neural activity (that is the Blood Oxygen Level Dependent signal) for individuals that are remitted from depression. This activity will be measured using functional magnetic resonance imaging (fMRI) while participants are performing tasks that use memory and learning. We will also match the remitted from depression group with healthy individuals that have never suffered from depression (control group). It is thought that subjects remitted from depression will not perform as well as the control group, on tasks that require memory and learning. It is also thought that, in tasks where those remitted from depression are able to perform as well as controls, they will need a higher level of brain activation. Individuals will be recruited from the general population and if suitable for the study, they will be asked to attend 7 visits during which time they will either take a new medication (that is not yet on the market) or a dummy drug (placebo).

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0213

• Date of REC Opinion

  14 May 2012

• REC opinion

  Further Information Favourable Opinion