Trial · NCT04975100
Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder
NCT04975100, Phase 4, Completed, All India Institute of Medical Sciences, Bhubaneswar
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder. Trials, record NCT04975100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04975100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder
- NCT number
- NCT04975100
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 60 participants, actual
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Conditions
- Major Depressive Disorder
- Interventions
- Sarcosine and SSRI, Placebo and SSRI
- First posted
- 2021-07-23
- Last updated
- 2023-07-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in severity of depressive symptoms from baseline. | 8 weeks | The change in symptoms of depression will be evaluated using Montgomery Asberg Depression Rating Scale score. Each item of the questionnaire yields a score of 0 to 6. The overall score ranges from 0 to 60. A higher score indicates more severe depression. |
| Secondary | Response rate | 8 weeks | Response rate is defined by percentage of patients showing 50% decrease in MADRS scores from baseline. |
| Secondary | Remission rate | 8 weeks | Remission rate is defined by percentage of patients achieving MADRS scores \<7 at 8-week follow-up. |
| Secondary | Severity of symptoms | Baseline | Severity of symptoms at baseline will be assessed by Clinical Global Impression severity scale. The Clinical Global Impression Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness. A higher score reflects more severe illness. |
| Secondary | Change in severity of symptoms | 8 weeks | Change in severity of symptoms will be assessed by Clinical Global Impression Improvement scale. The Clinical Global Impression Improvement scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. A lower value reflects better improvement of symptoms. |
| Secondary | Change in serum Brain Derived Neurotrophic Factor (BDNF) from baseline | 8 weeks | Serum BDNF levels will be measured using a commercially available human enzyme-linked immunosorbent assay (ELISA) kit. |
| Secondary | Change in serum Glycine from baseline | 8 weeks | Serum Glycine levels will be measured using a commercially available human enzyme-linked immunosorbent assay (ELISA) kit. |
| Secondary | Incidence of adverse drug reactions | 8 weeks | During the follow-up visit, occurrence of adverse events will be assessed by the nondirective questioning to the patient. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04975100
GET https://conductscience.org/api/trials/v1/NCT04975100/registered