Adjunct in the Treatment of Depressive DisorderNCT07893002
A Randomized, Open-Label, 52-Week Extension Study to Evaluate the Maintenance of Remission, Relapse Prevention, and Long-Term Safety of CreNeuroS™ in Patients With Major Depressive Disorder Who Achieved Remission Following an 8-Week Parent Study
A study testing CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily and CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily in people with Adjunct in the Treatment of Depressive Disorder, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.
Trial summary
This multicenter, randomized, open-label extension study will evaluate the maintenance of remission, relapse prevention, long-term clinical outcomes, and safety of CreNeuroS™ in participants with Major Depressive Disorder (MDD) who achieve protocol-defined remission (HAM-D-17 score ≤7) following completion of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adjunct in the Treatment of Depressive Disorder
- What is being tested?
- CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily and CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 11 Sep 2026to Oct 2027
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has completed the 8-week treatment phase of the parent study and achieved remission, defined as HAM-D-17 ≤7 at Week 8.
- Subject is clinically stable at the time of entering the transition/taper period, with no clinically significant worsening of depressive symptoms requiring immediate therapeutic intervention.
- Investigator considers tapering and discontinuation of Escitalopram clinically appropriate and safe for the subject.
- Subject completes the protocol-defined Escitalopram taper/transition period without experiencing relapse or clinically significant worsening of depressive symptoms requiring therapeutic intervention.
- Following completion of the transition period, subject remains clinically suitable for participation based on Investigator assessment, including depressive symptoms and overall clinical status, and has not experienced relapse during the transition/taper period.
- Subject does not require continuation, reinstatement or initiation of antidepressant therapy at the time of extension enrollment, except protocol-permitted rescue treatment where applicable.
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- Subject has no clinically significant adverse event, serious adverse event, or new medical/psychiatric condition that would preclude participation.
- Subject is willing and able to comply with the 52-week maintenance visits, assessments, treatment requirements and other study procedures.
- Subject provides written informed consent for participation in the Extension/Maintenance Phase before undertaking any extension-specific study procedure.
- Subject is considered medically and psychiatrically suitable for participation in the 52-week extension by the Investigator.
Who cannot join
- HAM-D-17 score >7 at Week 8 of the parent study.
- Clinically significant worsening of depressive symptoms during the Escitalopram taper/transition period that, in the Investigator's opinion, makes participation inappropriate.
- Subject meets the protocol-defined criteria for relapse during the transition/taper period or before extension enrollment.
- Subject requires continuation, reinstatement or initiation of antidepressant therapy due to clinical deterioration.
- Clinically significant Escitalopram discontinuation/withdrawal symptoms requiring continued antidepressant treatment or otherwise precluding participation in the extension.
- Any ongoing clinically significant adverse event or serious adverse event that may compromise subject safety or interfere with assessment of the extension outcomes.
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- Any new or worsening medical or psychiatric condition that, in the Investigator's opinion, makes the subject unsuitable for participation.
- Emergence of clinically significant suicidal ideation, suicidal behaviour or other safety concern requiring therapeutic intervention or a higher level of psychiatric care.
- Major protocol deviation during the parent study that, in the Investigator's opinion, may affect subject safety or the reliability of the extension assessments.
- Requirement for prohibited concomitant medications or therapies that may interfere with the study assessments.
- Pregnancy, planned pregnancy during the extension period, or breastfeeding, as applicable.
- Significant non-compliance with study procedures, treatment or visits during the parent study that raises concern regarding the subject's ability to comply with the extension.
- Subject withdraws consent or is unwilling to continue participation.
- Subject is unlikely to be available for the required 52-week follow-up or unable to comply with the study procedures.
- Any other condition or circumstance that, in the Investigator's judgment, makes the subject unsuitable for participation or places the subject at unacceptable risk.
- Relapse is defined as meeting ALL of the following criteria simultaneously: (1) HAM-D-17 score ≥18; (2) and an increase of ≥50% from the baseline score; (3) and hospitalization or adjustment of antidepressant treatment (e.g., change in medication) due to worsening depressive symptoms, as determined by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Jupiter Hospital and Research Centre
Vadodara, Gujarat, 390012
Anupsinh Chhasatia, +917600069616, anupsinhnm@gmail.com
About this study
Official title: An Investigator-Initiated Extension Study to Evaluate Maintenance of Remission, Prevention of Relapse, and Long-Term Safety of CreNeuroS™ CNS Fish Oil Plus Softgels in Subjects With Major Depressive Disorder Who Complete the Acute Treatment Phase of Protocol VRL-CT-26-006
This multicenter, randomized, open-label extension study will evaluate the maintenance of remission, relapse prevention, long-term clinical outcomes, and safety of CreNeuroS™ in participants with Major Depressive Disorder (MDD) who achieve protocol-defined remission (HAM-D-17 score ≤7) following completion of the 8-week acute treatment phase of parent study VRL-CT-26-006.
Eligible participants who remain clinically stable and provide written informed consent for the extension study will undergo a transition/taper period of approximately 2 weeks, which may be extended to 4 weeks if clinically warranted. No extension study intervention will be administered during this period.
Following the transition/taper period, eligible participants will be randomized in a 1:1:1 ratio to one of three maintenance groups: (1) observation without CreNeuroS™ supplementation; (2) CreNeuroS™ CNS Fish Oil Plus Softgels, one capsule orally once daily; or (3) CreNeuroS™ CNS Fish Oil Plus Softgels, two capsules orally once daily. Participants will be followed for 52 weeks after extension baseline to assess maintenance of remission, relapse, clinical outcomes, and safety.
Read the detailed description
The parent study had randomized 80 subjects. Based on the anticipated remission rate following the 8-week acute treatment phase, it is expected that approximately 50 to 70 subjects will be eligible for participation in the extension phase. The actual number of subjects enrolled will depend on the observed remission rate, subject willingness to continue participation, and investigator assessment of eligibility.
The extension phase is intended to generate long-term evidence on the maintenance of remission, prevention of relapse, and long-term safety of CreNeuroS™ CNS Fish Oil Plus Softgels.
- Being tested
- No intervention, CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily, CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No CreNeuroS™ supplementation;
CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once dailyDietary supplement
CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily
CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once dailyDietary supplement
CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Observation without CreNeuroS™ supplementation Receives: Other: No intervention |
| Group B | Experimental | CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsules orally once daily. Receives: Dietary Supplement: CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily |
| Group C | Experimental | CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsules orally once daily Receives: Dietary Supplement: CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy End point
Proportion of subjects remaining relapse-free during the 52-week maintenance period, where relapse is defined as meeting ALL of the following criteria simultaneously: (1) HAMD-17 total score ≥18; (2) and an increase of ≥50% from the baseline score; (3) and hospitalization or adjustment of antidepressant treatment (e.g., change in medication) due to worsening depressive symptoms, as determined by the Investigator.
Measured: Week 0, Weeks 12, 26, 40, and 52, based on HAM-D-17 score.
Secondary outcomes (1)
Safety end point
Incidence, severity and relatedness of AEs/SAEs, treatment discontinuations due to AEs, vital signs and other clinically relevant safety assessments.
Measured: Week 0, Weeks 12, 26, 40, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start11 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 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
- Model description
- Eligible subjects who successfully complete the acute treatment phase of Protocol VRL-CT-26-006, achieve remission, and provide written informed consent will be randomized in a 1:1:1 ratio
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07893002
- Sponsor's protocol ID
- VRL-CT-26-006, Version 2.0
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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