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Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder

NCT04975100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-25

No results posted yet for this study

Summary

One-third of the patients with major depressive disorder do not respond to conventional antidepressants that act through the mono-aminergic system. The available treatment modalities, including SSRIs, are slow to act and have a lag time before showing improvement in symptoms of patients. To overcome these treatment hurdles, add-on therapy to standard antidepressant drugs may lead to better therapeutic outcomes. Sarcosine, which is a nutraceutical, modulates glutamate neurotransmission has an ameliorative effect on the disease symptoms of depression and negative symptoms of schizophrenia. The only clinical study done on depressive patients by Huang et al. cannot be generalized due to certain inherent limitations. To date, there is no randomized controlled trial with add-on sarcosine to current antidepressant therapy to the best of our knowledge. So, we considered sarcosine can be the candidate drug for add-on therapy due to its multiple mechanisms on the glutaminergic system. Adding sarcosine to ongoing antidepressant therapy may either increase their response rate or decrease adverse drug reactions by decreasing the dose requirement or may show a quicker therapeutic effect. Hence, the present randomized controlled trial has been planned to evaluate the efficacy and safety of sarcosine as add-on therapy in major depressive disorder.

Conditions

Interventions

DRUG

Sarcosine and SSRI

Patients in the test group will get Sarcosine 500 mg capsules once daily as an add-on to ongoing SSRI treatment

DRUG

Placebo and SSRI

Patients in the control group will get identical-looking capsules containing placebo in addition to SSRI at an once daily dose

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • Rituparna Maiti, MD · AIIMS, Bhubaneswar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975100 on ClinicalTrials.gov