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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435744
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Drug: Simvastatin 20 mg Other: Placebo Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1-Simvastatin plus TAU, 2- Placebo plus TAU
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind plcaebo controlled trial
Primary Purpose: Treatment
Official Title: A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin with TAU
Participants will receive Simvastatin 20 mg added to TAU for 3 months
Drug: Simvastatin 20 mg
Simvastatin 20 mg added to TAU for 3 months.
Other Name: Statins

Placebo Comparator: Placebo Oral Tablet with TAU
Participants will receive placebo added to TAU for 3 months
Other: Placebo Oral Tablet
Matched placebo added to TAU for 3 months




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979) [ Time Frame: Week-2, Week-4, Week-8 and Week-12 ]
    The MADRS will be used as primary outcome measure in estimating depression severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435744


Contacts
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Contact: Muhammad I Husain +14165358501 ext 37838 ishrat.husain@camh.ca

Locations
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Pakistan
Civil Hospital Recruiting
Hyderabad, Pakistan
Contact: Moeen Ansari         
Civil Hospital Recruiting
Karachi, Pakistan, 75500
Contact: Prof Haider Naqvi         
Abbasi Shaheed Hospital Recruiting
Karachi, Pakistan
Contact: Sohail Ahmed         
Institute of Professional Psychology Recruiting
Rawalpindi, Pakistan
Contact: Asad Nizami         
Sponsors and Collaborators
Pakistan Institute of Living and Learning
King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03435744    
Other Study ID Numbers: PILL-DepSTAT-001
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors