ClinicalTrials.gg
Not yet recruitingNCT07645807VRL-CT-26-006Updated Jun 16, 2026

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

An interventional study of 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels and 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels in Adjunct in the Treatment of Depressive Disorder, sponsored by Sichuan Credit Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Sichuan Credit Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Adjunct in the Treatment of Depressive Disorder
03

In context

Lead sponsor

Sichuan Credit Pharmaceutical Co., Ltd. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects aged between 18 and 65 years, inclusive.
  2. Subjects with a clinical diagnosis of Major Depressive Disorder (MDD) as determined by the investigator or qualified psychiatrist, based on standard clinical judgment.
  3. Subjects with moderate to severe depression, defined as a Hamilton Depression Rating Scale (HAM-D-17) score ≥18 at both screening and baseline visits.
  4. 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 (≥2 weeks or ≥5 half-lives of the previous medication, whichever is longer) before baseline assessment.
  5. Subjects who are medically stable, as assessed by the investigator based on medical history, physical examination, and any relevant laboratory investigations.
  6. Subjects who are able and willing to provide written prior to participation in the study.
  7. Subjects who are willing and able to comply with study procedures, treatment regimen, and scheduled study visits.

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Presence of major psychiatric disorders other than MDD, including but not limited to:

    • Bipolar disorder
    • Schizophrenia or other psychotic disorders
  3. 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
    • cardiovascular disease
  4. Known or allergy to:

    • Escitalopram
    • Fish oil or omega-3 fatty acid or folic acid, or L-5-methyltetrahydrofolate supplements
  5. Pregnant or lactating women, or women planning to become pregnant during the study period.
  6. 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
  7. 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.
  8. History of substance abuse within 6 months prior to screening.
  9. Prior treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the current depressive episode.
  10. Initiation of new psychotherapy or change in psychotherapy intensity within 8 weeks prior to screening.
  11. Participation in other interventional or non-interventional studies within 3 months prior to screening.
  12. High dietary intake of fish (≥3 times per week) or use of fish oil/n-3 PUFA/folate supplements within the past 6 months.
  13. Moderate to severe anxiety disorders, as assessed by GAD-7.
  14. Participation in another clinical study within 30 days.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Test Arm

    CreNeuroSTM CNS Fish Oil Plus Softgels

    Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels

  • Placebo comparator
    Control Arm

    Placebo softgels

    Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels

Interventions

  • Combination product1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels

    1\. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels.

  • Combination product1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels

    1\. Escitalopram (as escitalopram oxalate) tablet and 2. Placebo softgels

06

What researchers measure

Primary outcomes

  1. Efficacy Endpoints

    Change in HAM-D-17 (Hamilton Depression Rating Scale - 17 items) total score from baseline to Week 2, Week 4, Week 6 and week 8. Score range (0 - 52): Higher scores indicate greater severity of depression, while lower score indicate improvement in depressive symptoms.

    Time frame: Baseline, Week 2, Week 4, Week 6 and week 8

07

Study locations

1 site
  • Jupiter Hospital and Research Centre
    Vadodara, Gujarat 390012, India
08

References and documents

Publications

  • 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. PubMed 34513348 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jan 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2026
First posted
Jun 12, 2026
StartEst.
Jun 11, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07645807
Collaborators
Vivotech Research Lab Pvt Ltd
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Jun 11, 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

Hitesh Shah
Contact
hitesh@creditpharma.com
+919821218347

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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