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

Last updated: August 25, 2021
Sponsor: Pakistan Institute of Living and Learning
Overall Status: Completed

Phase

3

Condition

Depression

Mood Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT03435744
PILL-DepSTAT-001
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • DSM-5 current major depressive episode
  • Must currently be on an antidepressant and must have had a non-response to >2 oralantidepressant treatments in the current episode (including the one they are currentlytaking).
  • Capacity to give informed consent
  • Willing to use adequate contraception
  • Give written informed consent

Exclusion

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 Design

Total Participants: 150
Study Start date:
January 01, 2019
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Civil Hospital

    Hyderabad,
    Pakistan

    Site Not Available

  • Abbasi Shaheed Hospital

    Karachi,
    Pakistan

    Site Not Available

  • Civil Hospital

    Karachi, 75500
    Pakistan

    Site Not Available

  • Institute of Professional Psychology

    Rawalpindi,
    Pakistan

    Site Not Available

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