An Investigator-Initiated, Randomized, Double-Blind, Double-Dummy Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.

NCT07645807 | Not Yet Recruiting

• 1 other identifier: VRL-CT-26-006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram.

Conditions

Adjunct in the Treatment of Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy Endpoints

  Change in HAM-D-17 total score from baseline to Week 2, Week 4, Week 6 and week 8

  Baseline, Week 2, Week 4, Week 6 and week 8

Study Arms (2)

Test Arm

EXPERIMENTAL

Escitalopram (as escitalopram oxalate) tablet +CreNeuroSTM CNS Fish Oil Plus Softgels

Combination Product: Escitalopram (as escitalopram oxalate) tablet +CreNeuroSTM CNS Fish Oil Plus Softgels

Control Arm

PLACEBO COMPARATOR

Escitalopram (as escitalopram oxalate) tablet +Placebo softgels

Combination Product: Escitalopram (as escitalopram oxalate) tablet +Placebo softgels

Interventions

Escitalopram (as escitalopram oxalate) tablet +Placebo softgels COMBINATION_PRODUCT

Escitalopram (as escitalopram oxalate) tablet +Placebo softgels

Control Arm

Escitalopram (as escitalopram oxalate) tablet +CreNeuroSTM CNS Fish Oil Plus Softgels COMBINATION_PRODUCT

Escitalopram (as escitalopram oxalate) tablet +CreNeuroSTM CNS Fish Oil Plus Softgels.

Test Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Credit Pharmaceutical Co., Ltd.: lead
• Vivotech Research Lab Pvt Ltd: collaborator

Study Sites (1)

Jupiter Hospital and Research Centre

Vadodara, Gujarat, 390012, India

Location

Related Publications (1)

• Sinha S, Chary S, Thakur P, Talluri L, Reddy M, Verma KK, Saha P, Gupta VB, Ramaiah KA, Khanum SZ. A Phase III Prospective Active and Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Major Depressive Disorder. Cureus. 2021 Jul 28;13(7):e16689. doi: 10.7759/cureus.16689. eCollection 2021 Jul.

  PMID: 34513348 BACKGROUND

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hitesh Shah

CONTACT

+919821218347; hitesh@creditpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

IN (1)