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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03435744
Other study ID # PILL-DepSTAT-001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2019
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source Pakistan Institute of Living and Learning
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Civil Hospital Hyderabad
Pakistan Abbasi Shaheed Hospital Karachi
Pakistan Civil Hospital Karachi
Pakistan Institute of Professional Psychology Rawalpindi

Sponsors (2)

Lead Sponsor Collaborator
Pakistan Institute of Living and Learning King's College London

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979) The MADRS will be used as primary outcome measure in estimating depression severity Week-2, Week-4, Week-8 and Week-12
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