Antidepressant controlled trial for negative symptoms in schizophrenia

• Research type

  Research Study

• Full title

  Antidepressant controlled trial for negative symptoms in schizophrenia (ACTIONS)

• IRAS ID

  25870

• Sponsor organisation

  Imperial College London

• Eudract number

  2009-009235-30

• Clinicaltrials.gov Identifier

  tba

• Research summary

  The negative symptoms of schizophrenia represent an important dimension of psychopathology, and reflect the absence or diminution of normal behaviours and functions. They include deficiencies in emotional responsiveness, drive, and emotional and social engagement. Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia, but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of negative symptoms of schizophrenia over a year. The study sample will be adults with an OPCRIT diagnosis of schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and characterised by persistent negative symptoms to a criterion level of severity. The study will be submitted for adoption by the Mental Health Research Network (MHRN) and conducted at seven centres: Bristol, North London, West London, South London, Manchester, Oxford, and Southampton. Consenting participants will be randomly assigned to be additional treatment with either citalopram (20mg/day for the first 4 weeks, followed by 40mg per day for the remainder of the study period) or identical placebo. 360 patients will be recruited over an 18-month period and each participant followed-up for 12 months. All outcomes scales will be administered at baseline and subsequently 3, 9 and 12 months. Primary outcomes will be quality-of-life at 3 and 12 months, and negative symptoms. Secondary outcomes will include the EuroQol EQ-5D for health economics. Symptoms will be comprehensively assessed, and other measures will assess social function, medication side effects, treatment adherence and cognition. The statistical analysis of the data will be guided by the CONSORT statement on reporting clinical trials.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/81

• Date of REC Opinion

  21 Oct 2009

• REC opinion

  Favourable Opinion