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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03435744

Acronym

DepSTAT

Enrollment

150

Registered

2018-02-19

Start date

2019-01-01

Completion date

2021-06-30

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression, Major Depressive Disorder

Brief 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.

Interventions

DRUGSimvastatin 20 mg

Simvastatin 20 mg added to TAU for 3 months.

OTHERPlacebo Oral Tablet

Matched placebo added to TAU for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind plcaebo controlled trial

Intervention model description

1-Simvastatin plus TAU, 2- Placebo plus TAU

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)	Week-2, Week-4, Week-8 and Week-12	The MADRS will be used as primary outcome measure in estimating depression severity

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026