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

NCT07804979 | Completed

• 1 other identifier: LahoreGeneralH20
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD); Treatment-resistant Depression (TRD)

Keywords

Major Depressive Disorder; Treatment-Resistant Depression; Minocycline; Celecoxib; Fluoxetine; Adjunctive Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Treatment Response Based on HAM-D Score

  Baseline to 12 weeks

Study Arms (2)

Group Minocycline

EXPERIMENTAL

Participants received minocycline 100 mg orally twice daily as adjunctive treatment, along with fluoxetine 20-40 mg orally per day, for 12 weeks.

Drug: Minocycline

Group Celecoxib

ACTIVE COMPARATOR

Participants received celecoxib 200 mg orally twice daily as adjunctive treatment, along with fluoxetine 20-40 mg orally per day, for 12 weeks.

Drug: Celecoxib

Interventions

Minocycline DRUG

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

Group Minocycline

Celecoxib DRUG

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

Group Celecoxib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; cyclopia sequence

Interventions

Minocycline; Celecoxib

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Farhana Ashraf

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: May 12, 2022
• Primary Completion: June 17, 2023
• Study Completion: September 15, 2023
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

PA (1)