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Completed

NCT Number: NCT07804979

Comparison of Efficacy of Minocyclin and Celecoxib as Adjunctive Treatment in Treatment Resistant Cases of Major Depressive Disorder

This randomized controlled study was conducted to compare the effectiveness of minocycline and celecoxib as add-on treatments in patients with treatment-resistant major depressive disorder. Treatment-resistant depression was defined as depression that had not adequately improved despite appropriate previous antidepressant treatment. A total of 78 patients aged 18-65 years were enrolled from the Psychiatry Department of Lahore General Hospital, Lahore, and were randomly assigned to two treatment groups. One group received minocycline 100 mg twice daily with fluoxetine 20-40 mg, while the other group received celecoxib 200 mg twice daily with fluoxetine 20-40 mg. Treatment was continued for 12 weeks.

Depressive symptoms were assessed using the Hamilton Depression Rating Scale (HAM-D) at baseline and during follow-up. The main outcome was the change in HAM-D score from baseline to the end of treatment. Treatment response was defined as a reduction of at least 50% in the HAM-D score, while remission was defined as a final HAM-D score of 7 or lower. The study was designed to test whether adding minocycline or celecoxib to fluoxetine would reduce depressive symptoms in treatment-resistant major depressive disorder and whether the degree of improvement differed between the two adjunctive treatments.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment-resistant Depression (TRD) cyclopia sequence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-65 years.
  • Patients of either gender.
  • Patients with a current diagnosis of Major Depressive Disorder.
  • Voluntary outpatients who were competent to provide informed consent.
  • Patients with a baseline Hamilton Depression Rating Scale (HAM-D) score >14.
  • Patients fulfilling the study definition of Treatment-Resistant Depression (TRD).

Exclusion criteria

  • Patients with psychotic depression.
  • Patients already taking either of the trial drugs, based on the medical record.
  • Patients with substance use disorder or dependence within the previous 3 months.
  • Pregnant women, women planning to conceive within 3 months, or breastfeeding women.
  • Patients with another primary psychiatric disorder already receiving treatment.
  • Patients with a history of intolerance or allergy to minocycline or celecoxib.
  • Patients with active renal, hepatic, cardiac, or serious dermatological illness.
  • Patients receiving concomitant penicillin therapy or anticoagulants.

Treatment and study plan

Minocycline

Drug

Minocycline 100 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.

Celecoxib

Drug

Celecoxib 200 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HAM-D) Score

    Time frame: Baseline and 12 weeks

    The primary outcome was the mean change in Hamilton Depression Rating Scale (HAM-D) score from baseline to the end of treatment. HAM-D was used to assess the severity of depressive symptoms. The change in HAM-D score was calculated by comparing the baseline score with the score obtained after 12 weeks of adjunctive treatment. A greater reduction in HAM-D score indicated greater improvement in depressive symptoms.

Secondary outcomes

  1. Treatment Response Based on HAM-D Score

    Time frame: Baseline to 12 weeks

    Treatment response was defined as a reduction of 50% or more in the HAM-D score from baseline during the 12-week treatment period. The proportion of participants achieving treatment response was assessed in each treatment group.

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Official study title

Comparison of Efficacy of Minocyclin and Celecoxib as Adjunctive Treatment in Treatment Resistant Cases of Major Depressive Disorder; A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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