A clinical trial to study the effects of the drug-simvastatin in patients with major depressive disorder

Effect of simvastatin as an add on to standard antidepressant therapy in patients with major depressive disorder in indian population: A randomized, double-blind placebo controlled study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084117

Enrollment

Registered

2025-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

Interventions

Intervention1: Simvastatin 20 mg: Simvastatin 20 mg will be given at night with food for 6 weeks Control Intervention1: Placebo: Glucose tablet identical in size and shape to simvastatin 20 mg will be

Eligibility

Inclusion criteria

Inclusion criteria: Patients on a stable dose (no change in dose) of antidepressants for 4 weeks. Patients willing to participate and give consent.

Exclusion criteria

Exclusion criteria: Patients with comorbid psychiatric or neurological disorders and substance use disorders except nicotine replacement therapy. Use of other lipid-lowering therapies. Significant liver disease (e.g., ALT/AST more than 3 times the upper limit of normal) or liver failure. History of rhabdomyolysis, unexplained muscle pain, weakness, or unexplained creatinine kinase (CK) more than 3 times the upper limit of normal. History of muscle disorders (e.g., rhabdomyolysis, myositis). Severe renal impairment Patients with LDL values less than 80 mg/dl and LDL values more than 190 mg/dl. Patients on immunomodulator therapy. Pregnancy or lactation or expecting to get pregnant during the treatment. Known hypersensitivity to simvastatin or other statins.

Design outcomes

Primary

Measure	Time frame
Reduction in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HAMD-17)Timepoint: At baseline and 6 weeks	—

Secondary

Measure	Time frame
Reduction in depression symptoms as assessed by the Montgomery sberg Depression Rating Scale (MADRS) after 6 weeks of add-on simvastatin therapy. To evaluate the change in pro-inflammatory cytokines after 6 weeks of add-on simvastatin therapy. To evaluate the change in serum IDO and BDNF after 6 weeks of add-on simvastatin therapy. To evaluate the change in serum lipid profile after 6 weeks of add-on simvastatin therapy. To evaluate the safety of add-on simvastatin.Timepoint: 0 and 6 weeks	—

Measure

Time frame

Reduction in depression symptoms as assessed by the Montgomery sberg Depression Rating Scale (MADRS) after 6 weeks of add-on simvastatin therapy. To evaluate the change in pro-inflammatory cytokines after 6 weeks of add-on simvastatin therapy. To evaluate the change in serum IDO and BDNF after 6 weeks of add-on simvastatin therapy. To evaluate the change in serum lipid profile after 6 weeks of add-on simvastatin therapy. To evaluate the safety of add-on simvastatin.Timepoint: 0 and 6 weeks

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Countries

India

Contacts

Public ContactDr Mokshit Meera Mukund

All India Institute of Medical Sciences, New Delhi

reetakh@gmail.com9711204141

Outcome results

None listed

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