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

August 25, 2021 updated by: Pakistan Institute of Living and Learning

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Hyderabad, Pakistan
        • Civil Hospital
      • Karachi, Pakistan
        • Abbasi Shaheed Hospital
      • Karachi, Pakistan, 75500
        • Civil Hospital
      • Rawalpindi, Pakistan
        • Institute of Professional Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simvastatin with TAU
Participants will receive Simvastatin 20 mg added to TAU for 3 months
Drug: Simvastatin 20 mg
Simvastatin 20 mg added to TAU for 3 months.
Other Names:
  • Statins
PLACEBO_COMPARATOR: Placebo Oral Tablet with TAU
Participants will receive placebo added to TAU for 3 months
Other: Placebo Oral Tablet
Matched placebo added to TAU for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week-2, Week-4, Week-8 and Week-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Collaborators

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILL-DepSTAT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Simvastatin 20 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe