Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial. (DepSTAT)
Primary Purpose
Treatment Resistant Depression, Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Simvastatin 20 mg
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility 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.
Sites / Locations
- Civil Hospital
- Civil Hospital
- Abbasi Shaheed Hospital
- Institute of Professional Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simvastatin with TAU
Placebo Oral Tablet with TAU
Arm Description
Participants will receive Simvastatin 20 mg added to TAU for 3 months
Participants will receive placebo added to TAU for 3 months
Outcomes
Primary Outcome Measures
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
The MADRS will be used as primary outcome measure in estimating depression severity
Secondary Outcome Measures
Full Information
NCT ID
NCT03435744
First Posted
February 9, 2018
Last Updated
August 25, 2021
Sponsor
Pakistan Institute of Living and Learning
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT03435744
Brief Title
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Acronym
DepSTAT
Official Title
A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
King's College London
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1-Simvastatin plus TAU, 2- Placebo plus TAU
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind plcaebo controlled trial
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin with TAU
Arm Type
Experimental
Arm Description
Participants will receive Simvastatin 20 mg added to TAU for 3 months
Arm Title
Placebo Oral Tablet with TAU
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo added to TAU for 3 months
Intervention Type
Drug
Intervention Name(s)
Simvastatin 20 mg
Other Intervention Name(s)
Statins
Intervention Description
Simvastatin 20 mg added to TAU for 3 months.
Intervention Type
Other
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Matched placebo added to TAU for 3 months
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
Description
The MADRS will be used as primary outcome measure in estimating depression severity
Time Frame
Week-2, Week-4, Week-8 and Week-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Civil Hospital
City
Hyderabad
Country
Pakistan
Facility Name
Civil Hospital
City
Karachi
ZIP/Postal Code
75500
Country
Pakistan
Facility Name
Abbasi Shaheed Hospital
City
Karachi
Country
Pakistan
Facility Name
Institute of Professional Psychology
City
Rawalpindi
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30762508
Citation
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.
Results Reference
derived
Learn more about this trial
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
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