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Simvastatin in the treatment of Depression

A double - blind placebo-controlled trial of simvastatin added to flouxetine in patients with moderate to severe major depression

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201205131556N43
Enrollment
40
Registered
2012-05-13
Start date
2012-06-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive episode. Depressive episode

Interventions

Intervention 1: Capsule Fluoxetine 40 mg/day plus Capsule simvastatin 20 mg/day as intervention group for 6 weeks. Intervention 2: Cap fluoxetine 40 mg/day plus Cap. placebo as control group for 6 wee
Treatment - Drugs
Placebo
Capsule Fluoxetine 40 mg/day plus Capsule simvastatin 20 mg/day as intervention group for 6 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Presence of Major Depressive Disorder based on DSM-IV criteria, Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22. Exclusion criteria: Presence of Psychosis, any diagnosis in Axis I and II, Receiving psychotropic medications, receiving any antidepressants during past one month or ECT during past two months, Presence of hypothyroidism or cardiovascular problems, hepatic disease, muscular disease, receiving other drugs affecting lipids, hypersensitivity to statins, LDL<80, high levels of liver enzymes at the beginning of the study, any life threatening condition, neurological disease, nursing and pregnant women

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity ofdepression. Timepoint: Baseline and weeks 2-4-6 after beginig of treatment. Method of measurement: by Hamiltion Depression Rating Scale 17-Item.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

S.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026