Pregabalin augmentation and neurocognitive functioning.

• Research type

  Research Study

• Full title

  The effects of pregabalin augmentation of antidepressant drugs on neurocognitive functioning in patients with generalized anxiety disorder

• IRAS ID

  120740

• Contact name

  David S Baldwin

• Sponsor organisation

  University of Southampton

• Eudract number

  2012-001779-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This research project is designed to evaluate the effects of the anxiolytic drug pregabalin on anxiety symptoms and some aspects of psychological functioning in patients with generalized anxiety disorder (GAD). The aims of this project are to establish whether pregabalin is effective and acceptable, and to evaluate its effects on information processing, in patients who have not responded to previous antidepressant treatment. Patients are only eligible to take part in the pregabalin treatment phase of the study if they have not responded to two courses (each lasting six weeks) of antidepressant treatment. One of these treatment courses can be historical (‘retrospective’ phase), but the other course has to have been delivered within the outpatient service at College Keep (‘prospective’ phase). In the pregabalin phase, patients are assessed at baseline, Week 1, Week 2, Week 4 and Week 6. Each of these assessments involves questions about anxiety and depressive symptoms, and any potential side effects of treatment. Participants would also be invited to take part in two short computerized tasks relating to the processing of information about emotions. A ‘fear potentiated startle paradigm’ examines eye blinks in response to sounds and visual images; and an ‘anti saccade task’ involves tracking eye movements in response to instructions.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  13/SC/0015

• Date of REC Opinion

  15 Feb 2013

• REC opinion

  Further Information Favourable Opinion