Status:
COMPLETED
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Lead Sponsor:
Pakistan Institute of Living and Learning
Collaborating Sponsors:
King's College London
Conditions:
Treatment Resistant Depression
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03435744
Start Date
January 1 2019
End Date
June 30 2021
Last Update
August 26 2021
Active Locations (4)
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1
Civil Hospital
Hyderābād, Pakistan
2
Civil Hospital
Karachi, Pakistan, 75500
3
Abbasi Shaheed Hospital
Karachi, Pakistan
4
Institute of Professional Psychology
Rawalpindi, Pakistan