Quetiapine XR in patients with Treatment Resistant Depression

• Research type

  Research Study

• Full title

  A randomised, 6-week, multicentre, open-label, rater-blinded parallel group study comparing Quetiapine extended release monotherapy and augmentation with Lithium augmentation in patients with Treatment Resistant Depression.

• IRAS ID

  6712

• Sponsor organisation

  AstraZeneca

• Eudract number

  2008-000908-91

• Clinicaltrials.gov Identifier

  NCT00789854

• Research summary

  Only one third to a half of patients with depression achieve adequate response to first round treatment with antidepressants. These patients are said to have ??treatment resistant? depression (TRD). They may need to be treated either with a different type of antidepressant or take another type of medication together with their current treatment, this is often called Ó?add-on or augmentation therapy?. There is still a need for further research to establish the best course of add-on therapy for TRD patients. A common add-on therapy is lithium. Recent research has shown that patients with TRD may benefit from the addition of another type of drug known as atypical neuroleptics. Quetiapine XR is an atypical neuroleptic. This study will compare how patients with TRD respond to treatment when either lithium or Quetiapine XR is added to their current antidepressant, or when Quetiapine XR alone replaces the current antidepressant treatment.TRD patients who are currently taking an antidepressant medication called a selective serotonin reuptake inhibitor or Venlafaxine will be recruited. Patients will be randomised to one of three treatment groups. Patients will either continue on their current antidepressant medication with the addition of Lithium or Quetiapine XR or they will discontinue their current medication and receive Quetiapine XR alone. Approximately 600 patients from several countries throughout Europe will take part; approximately 25 of these will be recruited from the UK. The overall study period will be for a maximum of 8 weeks; the treatment period will last for 6 weeks. The patient will attend the clinic for 6 visits, during the visits a variety of recognised scales to assess the patients response to treatment will be used as well as safety assessments including assessment of any adverse events, concomitant medications and blood samples will be collected.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/20

• Date of REC Opinion

  25 Mar 2009

• REC opinion

  Further Information Favourable Opinion