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

NCT03435744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Simvastatin 20 mg

Simvastatin 20 mg added to TAU for 3 months.

OTHER

Placebo Oral Tablet

Matched placebo added to TAU for 3 months

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Pakistan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03435744 on ClinicalTrials.gov