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CTRI Number  CTRI/2025/12/099987 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Investigator Initiated Trial]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to evaluate the safety and effectiveness of SNT-01 (Dextromethorphan 40 mg and Fluoxetine 10 mg) in reducing depressive symptoms in patients diagnosed with Major Depressive Disorder (MDD). 
Scientific Title of Study   A single center, randomized, double-blinded, active-controlled study to evaluate the safety and efficacy of SNT-01 (Dextromethorphan 40 mg and Fluoxetine 10 mg) compared to fluoxetine and placebo in reducing depressive symptoms in patients diagnosed with Major Depressive Disorder (MDD) over 6 weeks of treatment. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NT-CT-004-25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Kishore Sadula 
Designation  Principal investigator 
Affiliation  Disha Psychiatric Care 
Address  11-5-432/3, psychiatric department, Lakdikapul, Hyderabad, Telangana

Hyderabad
TELANGANA
500004
India 
Phone  9121488881  
Fax    
Email  ravikishore959@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Kishore Sadula 
Designation  Principal investigator 
Affiliation  Disha Psychiatric Care 
Address  11-5-432/3, psychiatric department, Lakdikapul, Hyderabad, Telangana

Hyderabad
TELANGANA
500004
India 
Phone  9121488881  
Fax    
Email  ravikishore959@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Kishore Sadula 
Designation  Principal investigator 
Affiliation  Disha Psychiatric Care 
Address  11-5-432/3, psychiatric department, Lakdikapul, Hyderabad, Telangana

Hyderabad
TELANGANA
500004
India 
Phone  9121488881  
Fax    
Email  ravikishore959@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Ravi kishore Sadula 
Address  Disha Psychiatric Care, 11-5-432/3, opposite krishna childrens hospital, Lakdikapul, Hyderabad, Telangana 500004 mail ravikishore959@gmail.com 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi Kishore Sadula  Disha Psychiatric Care  11-5-432/3, opposite krishna childrens hospital, Lakdikapul,
Hyderabad
TELANGANA 		 9121488881

ravikishore959@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vasavi Medical and Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoxetine 10 mg + Placebo  Treatment duration: 6 weeks Total visits: 9 visits Primary endpoint: Changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. 
Intervention  SNT-01 (Dextromethorphan 40 mg and Fluoxetine 10 mg)  Treatment duration: 6 weeks Total visits: 9 visits Primary endpoint: Changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Provides written informed consent to participate in the study, demonstrates an understanding of the procedures and study requirements, and agrees to adhere to study restrictions and attend required assessments.
2. Male or female, aged 18 to 75 years, inclusive.
3. Currently meets PHQ-9 criteria for Major Depressive Disorder without psychotic features, with a major depressive episode lasting at least 4 weeks at Visit 1.
4. Has a MADRS score more than 34 and a CGI-S score of greater than or equal to 4 at both Screening (Visit 1) and Baseline (Visit 2).
5. Exhibits normal physical examination findings and clinical laboratory test results from Screening (Visit 1), or has abnormal results deemed not clinically significant by the investigator.
6. Has a Body Mass Index between 18 and 40 kg/m², inclusive.
7. If female and of childbearing potential, has a negative urine pregnancy test at Visit 1 and Visit 2, is using an acceptable method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, double-barrier method), and does not plan to become pregnant during the study. Long-term abstinence is acceptable if the subject agrees to use double-barrier contraception if they decide to engage in sexual intercourse. 
 
ExclusionCriteria 
Details  1. History of any depressive episode with psychotic or catatonic features (schizoaffective disorder- depression type is included).
2. History of any manic, hypomanic, or mixed episode, including bipolar disorder (Type 1 or Type 2 and substance-induced manic, hypomanic, or mixed episodes (e.g., induced by antidepressants).
3. History of Schizophrenia, or any other psychotic disorder, (schizoaffective disorder- depression type are included).
4. History of panic disorder, with or without agoraphobia, obsessive-compulsive disorder, bulimia or anorexia nervosa, any persistent neurocognitive disorder, any other anxiety disorder that has been the primary focus of clinical attention for the six months prior to Screening, with MDD being a secondary focus.
5. Known hypersensitivity to SNT-01 or any components of the formulation.
6. Discontinuation of antidepressant drugs for less than 2 half-lives prior to study randomization (e.g., monoamine oxidase inhibitor discontinued for at least 2 weeks).
7. History of treatment-resistant depression, defined as two or more failed treatments of adequate dose and duration during the current depressive episode.
8. Treatment with SSRI1 in the last 4 weeks.
9. Receipt of light therapy within 2 weeks prior to screening.
10. Post-traumatic stress disorder (PTSD), if active within the past 3 months prior to Visit 1.
11. Borderline or antisocial personality disorder, or any other disorder severe enough to interfere with study participation.
12. Alcohol or substance use disorder (excluding nicotine or caffeine), if active within one year prior to Visit 1.
13. Currently taking any other antitussive medications.
14. Psychiatric hospitalization during the current depressive episode.
15. Psychiatric symptoms secondary to any other general medical condition.
16. Clinically significant risk of suicide or harm to self or others, determined by any of the following:
a. In the investigator’s judgment, the subject poses a significant suicide risk based on psychiatric interview or Columbia-Suicide Severity Rating Scale (C-SSRS) responses at Visit 1 or Visit 2 (e.g., a “yes” response to questions 4 or 5 on the screening C-SSRS, with the most recent episode occurring within the current depressive episode).
b. The subject has attempted suicide during the current depressive episode.
c. A MADRS Item 10 score of greter than or equal to 5 at Visit 1 or Visit 2.
17. Use of drugs that are strong inhibitors of CYP2D6 (e.g., wion, paroxetine, quinidine), as specified in the FDA’s Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.
18. Use of drugs that either inhibit CYP2D6, the primary enzyme responsible for metabolizing SSRI1.
19. Current use, or use within 14 days before Visit 1, of monoamine oxidase inhibitors (MAOIs), linezolid, or intravenous methylene blue.
20. Use of opioids (e.g., codeine, oxycodone, morphine) within 14 days before Visit 1.
21. The use of any prohibited medications, MAOIs, routine benzodiazepines (including PRN), and antidepressants, is not allowed within one week or two half-lives of the medication whichever is longer before Visit 2. Specifically, there must be a two-week washout period for MAOIs. The safe withdrawal from benzodiazepine treatment should be determined by the patient’s treating clinician and monitored by the principal investigator.
22. Patients on drugs that include ketamine or esketamine, and psychedelics available on street including MDMA, LSD, psilocybin.
23. A history of ECT (electroconvulsive therapy), VNS (vagus nerve stimulation), TMS (transcranial magnetic stimulation), or any experimental central nervous system treatments during the current episode or in the 6 months prior to Visit 1 (whichever is longer).
24. The need for concomitant treatment with any prohibited medications, supplements, or herbal products, including psychotropic drugs or those with potential psychotropic effects, except for:
Eszopiclone, zolpidem, zolpidem extended-release, zopiclone, or zaleplon for insomnia, provided these medications have been used consistently for 4 weeks prior to enrollment and at doses that do not exceed the maximum labeled amounts.
25. Initiation or discontinuation of psychotherapy for depression within 3 months of Visit 1, or plans to start, stop, or alter such therapy during the study. Support meetings or counseling (e.g., marital counseling) are permitted if they occur no more frequently than weekly and do not focus on the treatment of depression.
26. Ongoing, initiation, or discontinuation of phototherapy within 1 month of Visit 1.
27. Known HIV infection.
28. Clinically significant signs of active hepatitis B and/or C infection.
29. Any clinically significant abnormalities on screening laboratory tests, as determined by the study investigator and/or medical monitor.
30. Treatment with any investigational drug within 30 days prior to Visit 1.
31. Currently hospitalized or residing in an in-patient facility during the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This objective will be assessed primarily through changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6.  Baseline (Day 0) to end of the study (Day 42). 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="19" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a Investigator Initiated Trial. The title of the  study is a single center, randomized, double-blinded, active-controlled study to evaluate the safety and efficacy of SNT-01 (Dextromethorphan 40 mg and Fluoxetine 10 mg) compared to fluoxetine and placebo in reducing depressive symptoms in patients diagnosed with Major Depressive Disorder (MDD) over 6 weeks of treatment. The total of 42 patients with major depressive disorder will be enrolled into the study. The primary objective will be assessed primarily through changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. The total duration of the study shall be approximately 8 weeks including screening, treatment duration and follow-up period. A total of 09 visits will be scheduled to conduct the study. 
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