Evaluation of Efficacy and Safety of add-on Sarcosine in Patients With Major Depressive Disorder
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar