ATLANTIS
Research type
Research Study
Full title
AnTiconvuLsant AugmeNtation Trial In Schizophrenia: a randomised, pragmatic double-blind, placebo-controlled trial to assess the effectiveness of valproate augmentation of antipsychotic treatment in patients with residual psychotic symptoms
IRAS ID
275431
Contact name
Oliver Howes
Contact email
Sponsor organisation
King's College London
Eudract number
2020-000420-19
ISRCTN Number
ISRCTN77257074
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Schizophrenia is a severe mental illness that affects 1 in 100 people. The main treatment is with first-line antipsychotic drugs. However, for 1 in 3 patients, these drugs are ineffective at improving their symptoms.
In people whose illness is treatment resistant, the only alternative licensed medication is called clozapine. However, clozapine’s use is restricted because of safety concerns and requires careful physical health monitoring and frequent blood tests. This leaves many patients with no treatment option.
We aim to investigate a potential treatment for these patients. This is a drug called valproate and is not licensed for this purpose. A survey across UK NHS trusts found that in nearly 20% of patients it is used in this way, costing ~£60 million per year to the NHS. There is some evidence to support this practice, but the evidence is inconclusive. Thus, whilst adding valproate to antipsychotic treatment is widely used, it is unknown if it helps reduce symptoms, improves quality of life or is cost-effective. Therefore, we aim to conduct a study that will answer these questions.
Patients aged 18 and above of either gender who are not frail and have a diagnosis of schizophrenia or schizoaffective disorder with residual psychotic symptoms on their first-line antipsychotic will be recruited. They will be assigned to either a placebo (inactive substance) plus antipsychotic or valproate plus antipsychotic arm. This is a multi-centre UK trial in which the medication phase is for one year. The efficacy of this combination will be assessed using psychiatric assessments and the cost-effectiveness will be assessed using service use by patients over a period of one year. They will also be followed for long-term outcomes for up to four years from the start of the trial.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0247
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion