NCT05181527CompletedPhase 4
Repurposing of Dextromethorphan as an Adjunct Therapy in Patients With Major Depressive Disorder
Repurposing of Dextromethorphan as an Adjunct Therapy in Patients With Major Depressive Disorder: A Randomized, Group Sequential, Adaptive Design, Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Dec 2021
- Start date
- 10 Feb 2022
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Depression
- NCT number
- NCT05181527
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 10 Feb 2022 to the primary completion date, 30 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have been treated with Electro Convulsive Therapy (ECT) recently.
- Initiating or stopping formal psychotherapy within six weeks before enrolment.
Other illness
- 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 cognitive impairment.
- Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular,
- Substance abuse history of psychoactive agents.
Other
- Patients with suicidal thoughts or risk.
- neurological or endocrinal, respiratory dysfunction.
- Pregnant and lactating mothers.
Who the study is looking for
- 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 for less than equal to 4 weeks.
- Patients who have given written informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All India Institute of Medical Sciences (AIIMS) Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.