Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
Conditions
Interventions
Intervention1: Escitalopram (as escitalopram oxalate) tablet + CreNeuroSTM CNS Fish Oil Plus Softgels: Escitalopram (as escitalopram oxalate) tablets 10 mg orally once daily in the morning, which may
Sponsors
Sichuan Credit Pharmaceutical Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be included in the study: Male or female subjects aged between 18 years and 65 years, inclusive. Subjects with a clinical diagnosis of Major Depressive Disorder, 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 seventeen item total score of 18 or more at both Screening and Baseline visits. Subjects who are either planned to initiate treatment with escitalopram or have already started escitalopram therapy within 14 days prior to Screening. Any prior antidepressant therapy should have been discontinued with an adequate washout period of at least 14 days or five 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 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
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: High suicide risk, including active suicidal ideation with intent or plan, significant risk of suicide as considered by the investigator, or history of suicide attempt or self harm. Presence of major psychiatric disorders other than Major Depressive Disorder, including 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 uncontrolled hepatic disease, significant renal impairment, or clinically significant cardiovascular disease. Known hypersensitivity or allergy to escitalopram, fish oil, omega three fatty acids, folic acid, or L methyl tetrahydrofolate 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, or use of omega three fatty acid, fish oil, folic acid, or L methyl tetrahydrofolate supplements. History of substance abuse within 6 months prior to Screening. Prior treatment with electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation during the current depressive episode. Initiation of new psychotherapy or change in psychotherapy intensity within 8 weeks prior to Screening. Participation in any other interventional or non interventional clinical study within 3 months prior to Screening or within 30 days, whichever is longer. High dietary intake of fish, defined as consumption of fish 3 or more times per week, or use of fish oil, omega three polyunsaturated fatty acid, or folate supplements within the past 6 months. Moderate to severe anxiety disorders, as assessed by the Generalized Anxiety Disorder seven item scale. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram.Timepoint: Baseline, Week 2, Week 4, Week 6, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in depressive symptoms over time To evaluate clinical response & remission rates To assess the safety & tolerability of the study treatment To evaluate the impact on patient-reported outcomes (e.g., mood, sleep, anxiety)Timepoint: Baseline, Week 2, Week 4, Week 6, Week 8 | — |
Countries
India
Contacts
Public ContactKamlesh Londhe
Vivotech Research Lab Private Limited
Outcome results
None listed