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Studying the synergistic effect of fluoxetine with dextromethorphan in major depressive disorder

Evaluating the efficasy of Dextromethorphan and Fluoxetine combination therapy on improving symptoms of Major Depressive Disorder A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251026067775N1
Enrollment
86
Registered
2025-10-31
Start date
2025-11-11
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: This group is prescribed two drugs, fluoxetine and dextromethorphan. Fluoxetine is administered in the form of capsules at a dose of 10 mg per day, starting with th

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years diagnosis of major depressive disorder according to DSM-5-TR informed consent to enter the study

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding uncontrolled suicidal thoughts psychosis history of psychiatric illness or comorbid disorder such as bipolar disorder, schizophrenia, alcohol and substance use disorder, personality disorder ECT performed in the past two months uncontrolled medical illness such as thyroid disorders, cardiovascular disease, diabetes, autoimmune disease, active infection, neurological disorders (epilepsy, stroke, dementia), hematological, hepatic, renal diseases and cancer history of serotonin syndrome in the patient concomitant use of serotonergic drugs (triptans, tramadol, etc.), ... recent depressive episode more than one year

Design outcomes

Primary

MeasureTime frame
Depression score on the Hamilton Depression Rating Scale. Timepoint: Before the start of the study, 2, 4 and 8 weeks after the start of the study. Method of measurement: Hamilton Depression Rating Scale.

Secondary

MeasureTime frame
Response Rate: A reduction of more than 50% in the Hamilton Rating Scale is considered a response. Timepoint: Before the start of the study, 2, 4 and 8 weeks after the start of the study. Method of measurement: Hamilton Depression Rating Scale.;Remission rate: A reduction in the Hamilton Depression Rating scale to a number less than or equal to 7 is considered remission. Timepoint: Before the start of the study, 2, 4 and 8 weeks after the start of the study. Method of measurement: Hamilton Depression Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Safi

Gorgan University of Medical Sciences

nrm.safi13@gmail.com+98 17 3115 3377

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026