Treatment Resistant DepressionPhase 3DepSTATNCT03435744
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
A Phase 3 study testing Simvastatin 20 mg in people with Treatment Resistant Depression and Major Depressive Disorder, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder
- What is being tested?
- Simvastatin 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesPakistan
- Study dates
- 1 Jan 2019to 30 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Civil Hospital
Hyderābād
Civil Hospital
Karachi, 75500
Abbasi Shaheed Hospital
Karachi
Institute of Professional Psychology
Rawalpindi
About this study
Official title: A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
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.
- Being tested
- Simvastatin 20 mg, Placebo Oral Tablet
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 20 mgDrug
Also called Statins
Simvastatin 20 mg added to TAU for 3 months.
Placebo Oral TabletOther
Matched placebo added to TAU for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin with TAU | Experimental | Participants will receive Simvastatin 20 mg added to TAU for 3 months Receives: Drug: Simvastatin 20 mg |
| Placebo Oral Tablet with TAU | Placebo comparator | Participants will receive placebo added to TAU for 3 months Receives: Other: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
The MADRS will be used as primary outcome measure in estimating depression severity
Measured: Week-2, Week-4, Week-8 and Week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1-Simvastatin plus TAU, 2- Placebo plus TAU
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435744
- Sponsor's protocol ID
- PILL-DepSTAT-001
- Acronym
- DepSTAT
- Status last verified
- Aug 2021
- First submitted
- 9 Feb 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36808239Husain 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.
PubMed 30762508
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT03435744
- Acronym / sponsor ID
- DepSTAT / PILL-DepSTAT-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1-Simvastatin plus TAU, 2- Placebo plus TAU
| Arm | Type | Receives |
|---|---|---|
| Simvastatin with TAU | Experimental | Drug: Simvastatin 20 mgParticipants will receive Simvastatin 20 mg added to TAU for 3 months |
| Placebo Oral Tablet with TAU | Placebo comparator | Other: Placebo Oral TabletParticipants will receive placebo added to TAU for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 20 mgAlso: StatinsSimvastatin 20 mg added to TAU for 3 months. | Drug | Simvastatin with TAU |
| Placebo Oral TabletMatched placebo added to TAU for 3 months | Other | Placebo Oral Tablet with TAU |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 36808239Husain 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.
- Derived from this study: PubMed 30762508Husain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin 20 mg in people with Treatment Resistant Depression and Major Depressive Disorder, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979) (time frame: Week-2, Week-4, Week-8 and Week-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435744, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.