Status:

COMPLETED

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

Lead Sponsor:

All India Institute of Medical Sciences, Bhubaneswar

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief 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...

Detailed Description

Major depressive disorder (MDD) is a common psychiatric disorder with a substantial socioeconomic burden with a global prevalence rate of 16%. The underlying pathophysiology of depression is still not...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

February 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2023

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05181527

Start Date

February 10 2022

End Date

November 30 2023

Last Update

December 22 2023

Active Locations (1)

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All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, India, 751019