Adjunct in the Treatment of Depressive DisorderVRL-CT-26-006NCT07645807
Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
A study testing 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels in people with Adjunct in the Treatment of Depressive Disorder, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.
Trial summary
To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adjunct in the Treatment of Depressive Disorder
- What is being tested?
- 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 11 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels, 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus SoftgelsCombination product
- Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels.
1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgelsCombination product
- Escitalopram (as escitalopram oxalate) tablet and 2. Placebo softgels
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | CreNeuroSTM CNS Fish Oil Plus Softgels Receives: Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels |
| Control Arm | Placebo comparator | Placebo softgels Receives: Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, Week 4, Week 6 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start11 Jun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjunct in the Treatment of Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vivotech Research Lab Pvt Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645807
- Sponsor's protocol ID
- VRL-CT-26-006
- Acronym
- VRL-CT-26-006
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07645807
- Acronym / sponsor ID
- VRL-CT-26-006 / VRL-CT-26-006
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Vivotech Research Lab Pvt Ltd
- Study start
- 11 Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus SoftgelsCreNeuroSTM CNS Fish Oil Plus Softgels |
| Control Arm | Placebo comparator | Combination Product: 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgelsPlacebo softgels |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- High suicide risk, defined as:
- Presence of major psychiatric disorders other than MDD, including but not limited to:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels. | Combination product | Test Arm |
| 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels1. Escitalopram (as escitalopram oxalate) tablet and 2. Placebo softgels | Combination product | Control Arm |
Primary outcome
Efficacy Endpoints
Time frame: Baseline, Week 2, Week 4, Week 6 and week 8
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 34513348Sinha 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels in people with Adjunct in the Treatment of Depressive Disorder, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hitesh Shah (+919821218347, hitesh@creditpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoints (time frame: Baseline, Week 2, Week 4, Week 6 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.