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

Summary

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.

Timeline

Start

2019-01-01

Primary completion

2021-06-30

Completion

2021-06-30

Outcome

Missed primary endpoint

paper did not differ significantly between groups (estimated mean difference for simvastatin vs placebo, -0.61; 95% CI, -3.69 to 2.46; P = .70). PMID 36808239 ↗

Publications

• Husain MI, Chaudhry IB, Khoso AB, Kiran T, Khan N, Ahmad F, Hodsoll J, Husain MO, Naqvi HA, Nizami AT, Chaudhry N, Khan HA, Minhas F, Meyer JH, Ansari MA, Mulsant BH, Husain N, Young AH. Effect of Adjunctive Simvastatin on Depressive Symptoms Among Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230147. doi: 10.1001/jamanetworkopen.2023.0147.
• Husain MI, Chaudhry IB, Khoso AB, Husain MO, Rahman RR, Hamirani MM, Hodsoll J, Carvalho AF, Husain N, Young AH. Adjunctive simvastatin for treatment-resistant depression: study protocol of a 12-week randomised controlled trial. BJPsych Open. 2019 Jan;5(1):e13. doi: 10.1192/bjo.2018.84.

Drugs

Indications