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

Major Depressive Disorder Clinical Trial

— DepSTAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435744
• Other study ID #: PILL-DepSTAT-001
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment Resistant Depression

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