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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Treatment Resistant Depression Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1-Simvastatin plus TAU, 2- Placebo plus TAU

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind plcaebo controlled trial

Study Groups

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Simvastatin with TAU

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

Group Type EXPERIMENTAL

Simvastatin 20 mg

Intervention Type DRUG

Simvastatin 20 mg added to TAU for 3 months.

Placebo Oral Tablet with TAU

Participants will receive placebo added to TAU for 3 months

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type OTHER

Matched placebo added to TAU for 3 months

Interventions

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Simvastatin 20 mg

Simvastatin 20 mg added to TAU for 3 months.

Intervention Type DRUG

Placebo Oral Tablet

Matched placebo added to TAU for 3 months

Intervention Type OTHER

Other Intervention Names

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Statins

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No