Trial | NCT03435744  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
Study Started
Jan 01
2019
Primary Completion
Jun 30
2021
Study Completion
Jun 30
2021
Last Update
Aug 26
2021

Drug Simvastatin 20 mg

Simvastatin 20 mg added to TAU for 3 months.

  • Other names: Statins

Other Placebo Oral Tablet

Matched placebo added to TAU for 3 months

Simvastatin with TAU Experimental

Participants will receive Simvastatin 20 mg added to TAU for 3 months

Placebo Oral Tablet with TAU Placebo Comparator

Participants will receive placebo added to TAU for 3 months

Criteria 

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.
No Results Posted