Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.

The study population will include patients with moderate to severe Major Depressive Disorder who are either treatment-naïve or have discontinued prior antidepressant therapy following an appropriate washout period prior to baseline.

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:

• Planned to initiate treatment with escitalopram, or
• Have already started escitalopram therapy within ≤2 weeks prior to screening, provided that any prior antidepressant therapy was discontinued with an adequate washout period (≥2 weeks or ≥5 half-lives of the previous medication, whichever is longer) before baseline assessment.
• 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 active suicidal ideation with intent or plan, or
• Subject considered by the investigator to be at significant risk of suicide.
• History of suicide attempt or self-harm
• Presence of major psychiatric disorders other than MDD, including but not limited to:

• Bipolar disorder
• Schizophrenia or other psychotic disorders
• 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:

• Uncontrolled hepatic (liver) disease
• Significant renal (kidney) impairment
• Clinically significant cardiovascular disease
• Known hypersensitivity or allergy to:

• Escitalopram
• Fish oil or omega-3 fatty acid or folic acid, or L-5-methyltetrahydrofolate supplements
• 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:

• Other antidepressants (unless in the process of being switched to escitalopram)
• use of omega-3 or fish oil or folic acid, or L-5-methyltetrahydrofolate supplements
• 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.
• Prior treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the current depressive episode.
• Initiation of new psychotherapy or change in psychotherapy intensity within 8 weeks prior to screening.
• Participation in other interventional or non-interventional studies within 3 months prior to screening.
• High dietary intake of fish (≥3 times per week) or use of fish oil/n-3 PUFA/folate supplements within the past 6 months.
• Moderate to severe anxiety disorders, as assessed by GAD-7.
• Participation in another clinical study within 30 days.