NCT03435744

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Simvastatin 20 mg	Simvastatin 20 mg added to TAU for 3 months.
OTHER	Placebo Oral Tablet	Matched placebo added to TAU for 3 months

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-02-19
• Last updated: 2021-08-26

Locations

4 sites across 1 country: Pakistan