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| Name | Class |
|---|---|
| King's College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin with TAU | Experimental | Participants will receive Simvastatin 20 mg added to TAU for 3 months |
|
| Placebo Oral Tablet with TAU | Placebo Comparator | Participants will receive placebo added to TAU for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 20 mg | Drug | Simvastatin 20 mg added to TAU for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civil Hospital | Hyderābād | Pakistan | ||||
| Civil Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36808239 | Derived | Husain MI, Chaudhry IB, Khoso AB, Kiran T, Khan N, Ahmad F, Hodsoll J, Husain MO, Naqvi HA, Nizami AT, Chaudhry N, Khan HA, Minhas F, Meyer JH, Ansari MA, Mulsant BH, Husain N, Young AH. Effect of Adjunctive Simvastatin on Depressive Symptoms Among Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230147. doi: 10.1001/jamanetworkopen.2023.0147. | |
| 30762508 |
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1-Simvastatin plus TAU, 2- Placebo plus TAU
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Double blind plcaebo controlled trial
| Placebo Oral Tablet | Other | Matched placebo added to TAU for 3 months |
|
| Karachi |
| 75500 |
| Pakistan |
| Abbasi Shaheed Hospital | Karachi | Pakistan |
| Institute of Professional Psychology | Rawalpindi | Pakistan |
| Derived |
| Husain MI, Chaudhry IB, Khoso AB, Husain MO, Rahman RR, Hamirani MM, Hodsoll J, Carvalho AF, Husain N, Young AH. Adjunctive simvastatin for treatment-resistant depression: study protocol of a 12-week randomised controlled trial. BJPsych Open. 2019 Jan;5(1):e13. doi: 10.1192/bjo.2018.84. |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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