CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Selective Serotonin Reuptake Inhibitors +2 moredrug
Likely dose
Dextromethorphan 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05181527
NCT05181527Phase 4Completed

Repurposing of Dextromethorphan as an Adjunct Therapy in Patients With Major Depressive Disorder: A Randomized, Group Sequential, Adaptive Design, Controlled Clinical Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Jan 6, 2022·Updated Dec 22, 2023

In Brief

A Phase 4 clinical trial evaluating Selective Serotonin Reuptake Inhibitors, Dextromethorphan, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Therapeutic latency, lack of efficacy, and adverse drug reactions are the major concerns in current antidepressant therapies. One-third of the patients with 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 N-methyl-D-aspartate receptors (like ketamine) with additional serotonin transporter and norepinephrine transporter inhibitory action. So, the investigators expect that adding dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) regimen can improve clinical outcomes in major depressive disorder. The 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJan 6, 2022
Enrollment StartFeb 10, 2022
Primary CompletionSep 30, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.5 years ago

Interventions

Selective Serotonin Reuptake Inhibitorsdrug

Patients in both the study arms will receive SSRI for 8 weeks.

Dextromethorphandrug

Patients in the test group will get Dextromethorphan 30 mg once daily orally as an add-on to ongoing SSRI treatment for 8 weeks.

Placebodrug

Patients in the control group will get placebo tablet once daily orally as an add-on to ongoing SSRI treatment for 8 weeks.