Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)
Conditions
Keywords
Major Depressive Disorder, Treatment-Resistant Depression, Minocycline, Celecoxib, Fluoxetine, Adjunctive Drug Therapy
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.
Interventions
DRUGMinocycline
Minocycline 100 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.
DRUGCelecoxib
Celecoxib 200 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HAM-D) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response Based on HAM-D Score | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFarhana Ashraf
Lahore General Hospital, Lahore
Outcome results
None listed