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

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Civil Hospital, Hyderābād, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simvastatin 20 mg

Drug

Simvastatin 20 mg added to TAU for 3 months.

Other names: Statins

Placebo Oral Tablet

Other

Matched placebo added to TAU for 3 months

Primary outcomes

Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)

Time frame: Week-2, Week-4, Week-8 and Week-12

The MADRS will be used as primary outcome measure in estimating depression severity

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

King's College London

Registry information

Official study title

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

Acronym: DepSTAT

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Feb 19, 2018
Registry last updated: Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed