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

Pakistan Institute of Living and Learning150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Treatment Resistant Depression Major Depressive Disorder

Interventions

Simvastatin 20 mgDRUG

Simvastatin 20 mg added to TAU for 3 months.

Placebo Oral TabletOTHER

Matched placebo added to TAU for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Civil Hospital

Hyderābād, Pakistan

Civil Hospital

Karachi, Pakistan

Abbasi Shaheed Hospital

Karachi, Pakistan

Institute of Professional Psychology

Rawalpindi, Pakistan

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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