Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With… (NCT07645807) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
India80 participantsStarted 2026-06-11
Plain-language summary
To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged between 18 and 65 years, inclusive.
. Subjects with a clinical diagnosis of Major Depressive Disorder (MDD) as determined by the investigator or qualified psychiatrist, based on standard clinical judgment.
. Subjects with moderate to severe depression, defined as a Hamilton Depression Rating Scale (HAM-D-17) score ≥18 at both screening and baseline visits.
. Subjects who are either:
. Subjects who are medically stable, as assessed by the investigator based on medical history, physical examination, and any relevant laboratory investigations.
. Subjects who are able and willing to provide written informed consent prior to participation in the study.
. Subjects who are willing and able to comply with study procedures, treatment regimen, and scheduled study visits.
Exclusion criteria
. High suicide risk, defined as:
. Presence of major psychiatric disorders other than MDD, including but not limited to:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines a specific fish oil supplement called CreNeuroS™ with the antidepressant escitalopram — is escitalopram even the right medication for my situation, and would starting it now through a trial make sense compared to other first-line treatment options?
2Since this trial is listed as 'not yet recruiting,' do you know when it's expected to open, and would waiting for it delay me getting treatment I might need sooner?
3The trial is listed as Phase NA, which I'm not sure how to interpret — what does that mean for how much is already known about the safety of combining this fish oil product with escitalopram?
4The study is double-blind and double-dummy, meaning neither I nor my doctor would know whether I'm getting the fish oil or a placebo alongside escitalopram — how comfortable are you with me potentially going several months without knowing which one I'm receiving?
5Are there already established omega-3 or fish oil supplements that doctors use alongside antidepressants, and how does what's being studied here compare to those options you could prescribe or recommend outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Presence of severe or unstable medical conditions that may interfere with study participation or pose a risk to the subject, including but not limited to:
. Known hypersensitivity or allergy to:
. Pregnant or lactating women, or women planning to become pregnant during the study period.
. Use of concomitant medications or treatments that may confound study outcomes, including:
. Any condition or circumstance which, in the opinion of the investigator, may compromise subject safety, adherence to study procedures, or the integrity of study data.
. History of substance abuse within 6 months prior to screening.