RECOVERY[OCTUMI-4]

• Research type

  Research Study

• Full title

  RECOVERY[OCTUMI-4]: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A randomised, double-blind, 2x2 factorial trial

• IRAS ID

  22053

• Contact name

  John Geddes

• Eudract number

  2009-014469-19

• ISRCTN Number

  ISRCTN32434568

• Research summary

  Current treatments for schizophrenia (primarily antipsychotics) are not fully effective and many patients remain symptomatic. There is some evidence that adding mirtazapine to existing treatment can lead to a reduction in symptoms and that this reduction may be greatest for negative symptoms which include apathy, lack of emotion, and poor social functioning. RECOVERY is a randomised placebo-controlled trial designed to evaluate the effect of adding mirtazapine to antipsychotic treatment. The primary outcome measure will be reduction of symptoms after 12-weeks treatment with mirtazapine or placebo measured on the Positive and Negative Syndrome Scale (PANSS). Secondary outcomes will include reduction of negative symptoms measured on the PANSS negative symptom subscale and tolerability of mirtazapine.Mental illness appears to be associated with an increased risk of folate deficiency and there is some evidence that folic acid treatment can improve outcomes when added to other treatments for schizophrenia. RECOVERY therefore has a 2x2 factorial design in which secondary analyses will explore the effect of adding folic acid or placebo to existing treatments on PANSS total and on negative symptoms scores.It is reasonable to predict that any effects of folic acid will be greatest in people with low baseline folate levels. Blood samples will therefore be collected prior to randomisation and after 12 weeks treatment to explore the effects of low baseline folate and any subsequent increase in folate levels. Furthermore there are two genetic polymorphisms which are thought to flunce folate levels. Participants will be asked to consent for the blood samples to be used to determine their genotype so that the correlation between genotype and response to treatment can be assessed.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/24

• Date of REC Opinion

  26 Jul 2010

• REC opinion

  Further Information Favourable Opinion