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

Pakistan Institute of Living and Learning

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Treatments: Other: Placebo Oral Tablet; Drug: Simvastatin 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03435744

PILL-DepSTAT-001

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups, including a placebo group

Simvastatin with TAU

Experimental group

Description:

Participants will receive Simvastatin 20 mg added to TAU for 3 months

Treatment:

Drug: Simvastatin 20 mg

Placebo Oral Tablet with TAU

Placebo Comparator group

Description:

Participants will receive placebo added to TAU for 3 months

Treatment:

Other: Placebo Oral Tablet