Repurposing of Dextromethorphan as an Adjunct Therapy in Patients With Major Depressive Disorder

Not yet recruiting
Trial end date:
Target enrollment:
Participant gender:
Therapeutic latency, lack of efficacy, and adverse drug reactions are the major concerns in current antidepressant therapies. One-third of the patients with the major depressive disorder do not respond to conventional antidepressants that act through the monoaminergic system. To overcome these treatment hurdles, add-on therapy to standard antidepressant drugs may lead to better therapeutic outcomes. The recent discovery of the rapid and sustained antidepressant effect of subanesthetic dose of ketamine led to many extensive clinical and preclinical research in the recent past and has established the possibilities of NMDA receptors as a potential drug target for depression. As repeated doses of ketamine are related to abusive potential and adverse effects, the search for a similar antidepressant agent with a better safety profile is essential. Dextromethorphan has the property of noncompetitively blocking NMDA receptors (like ketamine) with additional SERT and NET inhibitory action. So, we can expect that adding Dextromethorphan to the SSRI regimen can improve clinical outcomes in major depressive disorder. Our literature search found that to date, there is no randomized controlled trial on Dextromethorphan as add-on therapy to first-line antidepressants like SSRIs. So, the present randomized controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to SSRIs in major depressive disorder.
Phase 4
Accepts Healthy Volunteers?
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Inclusion Criteria:

Patients diagnosed with major depressive disorder of either gender within the age group of
18-65 years Patients with MADRS score ≥ 7 and ≤ 34 (patients having mild to moderate MDD).
Patients who are on a stable dose of Sertraline 50 mg or any other Selective Serotonin
Reuptake Inhibitor (SSRI) therapy in equivalent dose. Patients who have given written
informed consent.

Exclusion Criteria:

Patients who have been treated with Electro Convulsive Therapy (ECT) recently. History of
epilepsy, or other major neurological or medical disorders, head trauma.

Patients with a history of Bipolar Depression (BPD). Patients with schizophrenia or other
psychotic disorder. Patients with suicidal thoughts or risk. Patients with cognitive
impairment. Initiating or stopping formal psychotherapy within six weeks before enrolment.
Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular,
neurological or endocrinal, respiratory dysfunction. Substance abuse history of
psychoactive agents. Pregnant and lactating mothers.