Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Official Title  ICMJE A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Treatment Resistant Depression
  • Major Depressive Disorder
Intervention  ICMJE
  • Drug: Simvastatin 20 mg
    Simvastatin 20 mg added to TAU for 3 months.
    Other Name: Statins
  • Other: Placebo Oral Tablet
    Matched placebo added to TAU for 3 months
Study Arms  ICMJE
  • Experimental: Simvastatin with TAU
    Participants will receive Simvastatin 20 mg added to TAU for 3 months
    Intervention: Drug: Simvastatin 20 mg
  • Placebo Comparator: Placebo Oral Tablet with TAU
    Participants will receive placebo added to TAU for 3 months
    Intervention: Other: Placebo Oral Tablet
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muhammad I Husain +14165358501 ext 37838 ishrat.husain@camh.ca
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435744
Other Study ID Numbers  ICMJE PILL-DepSTAT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pakistan Institute of Living and Learning
Study Sponsor  ICMJE Pakistan Institute of Living and Learning
Collaborators  ICMJE King's College London
Investigators  ICMJE Not Provided
PRS Account Pakistan Institute of Living and Learning
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP