Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.

A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression

In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.

Inclusion Criteria:

• DSM-5 current major depressive episode
• Must currently be on an antidepressant and must have had a non-response to >2 oral antidepressant treatments in the current episode (including the one they are currently taking).
• Capacity to give informed consent
• Willing to use adequate contraception
• Give written informed consent

Exclusion Criteria:

• Primary psychotic or bipolar disorder
• History of intolerance to statins or presence of any contraindication to statins
• Presence of any serious medical condition or neurological problem
• Presence of autoimmune or inflammatory disorder
• Alcohol or drug dependence
• Active suicidal ideation
• Pregnant or breast-feeding.