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NCT03435744: DepSTAT
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Phase 3 trial testing Simvastatin 20 mg in Treatment Resistant Depression in 150 participants. Completed in 30 June 2021.
30 June 2021
Quick facts
| Lead sponsor | Pakistan Institute of Living and Learning |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 January 2019 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 4 locations across Pakistan |
Drugs / interventions tested
- Simvastatin 20 mg — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Treatment Resistant Depression — all drugs for Treatment Resistant Depression →
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Pakistan Institute of Living and Learning
Who can join
Adults 18 to 75, any sex, with Treatment Resistant Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treatment resistance in psychiatry: state of the art and new directions.
Howes OD, Thase ME, Pillinger T. · · 2022 · cited 250× · PMID 34257409 · DOI 10.1038/s41380-021-01200-3 -
Novel drug developmental strategies for treatment-resistant depression.
Borbély É, Simon M, Fuchs E, Wiborg O, et al · · 2022 · cited 70× · PMID 34822719 · DOI 10.1111/bph.15753 -
Adjunctive simvastatin for treatment-resistant depression: study protocol of a 12-week randomised controlled trial.
Husain MI, Chaudhry IB, Khoso AB, Husain MO, et al · · 2019 · cited 15× · PMID 30762508 · DOI 10.1192/bjo.2018.84 -
Effect of Adjunctive Simvastatin on Depressive Symptoms Among Adults With Treatment-Resistant Depression: A Randomized Clinical Trial.
Husain MI, Chaudhry IB, Khoso AB, Kiran T, et al · · 2023 · cited 13× · PMID 36808239 · DOI 10.1001/jamanetworkopen.2023.0147 -
Associations between C-reactive protein and individual symptoms of depression in a lower-middle income country.
Fellows E, Jones BDM, Hodsoll J, Husain N, et al · · 2024 · cited 3× · PMID 39359158 · DOI 10.1192/bjo.2024.735 -
ACNP 61<sup>st</sup> Annual Meeting: Poster Abstracts P1 - P270.
· 2022 · PMID 36456693 · DOI 10.1038/s41386-022-01484-1
Verify or expand the search:
- PubMed search for NCT03435744
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Treatment Resistant Depression
Currently open trials in the same condition.
- NCT07183748 — Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression · Phase 2 · recruiting
- NCT06938841 — Maintenance rTMS for Depression (Maitr-De) · NA · recruiting
- NCT06236711 — Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) · NA · active not recruiting
- NCT05774665 — Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression · Phase 2 · active not recruiting
- NCT06895863 — COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression · NA · recruiting
Other Pakistan Institute of Living and Learning trials
Trials by the same sponsor.
- NCT07015944 — Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan · NA · recruiting
- NCT06442007 — Universally Delivered Interventions for Young People · NA · not yet recruiting
- NCT07188597 — Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis · NA · recruiting
- NCT03974620 — Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia · NA · not yet recruiting
- NCT05933850 — Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03435744 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pakistan Institute of Living and Learning
- Last refreshed: 26 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03435744.
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