| CTRI Number |
CTRI/2025/04/084117 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of the drug-simvastatin in patients with major depressive disorder |
|
Scientific Title of Study
|
Effect of simvastatin as an add on to standard antidepressant therapy in patients with major depressive disorder in indian population: A randomized, double-blind placebo controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mokshit Meera Mukund |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 4008, Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9751668158 |
| Fax |
|
| Email |
MOKS55LMS@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KH Reeta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9711204141 |
| Fax |
|
| Email |
reetakh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mokshit Meera Mukund |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 4008, Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9751668158 |
| Fax |
|
| Email |
moks55lms@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, ANSARI NAGAR EAST, NEW DELHI - 110029, INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
All India Institute of Medical Sciences, Ansari Nagar east, New Delhi - 110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mokshit Meera Mukund |
All India Institute of Medical Sciences, Ansari Nagar East |
Room no 1-24, 2nd floor, Department of Psychiatry, AIIMS RAK OPD
New Delhi
DELHI |
9751668158
MOKS55LMS@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Glucose tablet identical in size and shape to simvastatin 20 mg will be given at night with food for 6 weeks. |
| Intervention |
Simvastatin 20 mg |
Simvastatin 20 mg will be given at night with food for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients on a stable dose (no change in dose) of antidepressants for 4 weeks.
Patients willing to participate and give consent.
|
|
| ExclusionCriteria |
| Details |
Patients with comorbid psychiatric or neurological disorders and substance use disorders except nicotine replacement therapy.
Use of other lipid-lowering therapies.
Significant liver disease (e.g., ALT/AST more than 3 times the upper limit of normal) or liver failure.
History of rhabdomyolysis, unexplained muscle pain, weakness, or unexplained creatinine kinase (CK) more than 3 times the upper limit of normal.
History of muscle disorders (e.g., rhabdomyolysis, myositis).
Severe renal impairment
Patients with LDL values less than 80 mg/dl and LDL values more than 190 mg/dl.
Patients on immunomodulator therapy.
Pregnancy or lactation or expecting to get pregnant during the treatment.
Known hypersensitivity to simvastatin or other statins. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HAMD-17) |
At baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in depression symptoms as assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) after 6 weeks of add-on simvastatin therapy.
To evaluate the change in pro-inflammatory cytokines after 6 weeks of add-on simvastatin therapy.
To evaluate the change in serum IDO and BDNF after 6 weeks of add-on simvastatin therapy.
To evaluate the change in serum lipid profile after 6 weeks of add-on simvastatin therapy.
To evaluate the safety of add-on simvastatin. |
0 and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| This study will use a prospective, randomized, double-blind, placebo-controlled design to investigate the effects of add-on Simvastatin therapy over 6 weeks on patients with major depressive disorder (MDD). The primary aim is to assess changes in depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17). Secondary objectives include evaluating changes in serum IDO and serum BDNF levels, changes in proinflammatory cytokines, and the Montgomery-Åsberg Depression Rating Scale (MADRS), as well as assessing the safety of the simvastatin therapy. Participants clinically diagnosed with major depressive disorder and on stable antidepressant therapy for at least 4 weeks. They will be screened in the psychiatry outpatient department at AIIMS, New Delhi. Eligible participants meeting the inclusion criteria will be randomly assigned to either the treatment group, receiving simvastatin 20 mg, or the placebo group, receiving a matching placebo. Both groups will continue their ongoing antidepressant regimen for 6 weeks. At enrollment, demographic data, depression scores, and antidepressant treatment-related data will be collected. Blood samples will be taken to measure depression-related markers (BDNF and IDO). After 6 weeks of supplementation, all baseline parameters will be reassessed. Changes in depression scores from baseline to post-supplementation will be calculated and presented as mean (SD). Any adverse events during the intervention will be monitored and reported to the corresponding authorities. |
|