Major Depressive Disorder (MDD)NCT07804979
Comparison of Efficacy of Minocyclin and Celecoxib as Adjunctive Treatment in Treatment Resistant Cases of Major Depressive Disorder
A study testing Minocycline and Celecoxib in people with Major Depressive Disorder (MDD) and Treatment-resistant Depression (TRD), run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD)
- What is being tested?
- Minocycline and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of Efficacy of Minocyclin and Celecoxib as Adjunctive Treatment in Treatment Resistant Cases of Major Depressive Disorder; A Randomized Controlled Study
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.
- Being tested
- Minocycline, Celecoxib
- Keywords
- Major Depressive Disorder, Treatment-Resistant Depression, Minocycline, Celecoxib, Fluoxetine, Adjunctive Drug Therapy
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline 100 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.
CelecoxibDrug
Celecoxib 200 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Treatment Response Based on HAM-D Score
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start12 May 2022
- Primary completion17 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Farhana Ashraf, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804979
- Sponsor's protocol ID
- LahoreGeneralH20
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Minocyclin and Celecoxib as Adjunctive Treatment in Treatment Resistant Cases of Major Depressive Disorder; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07804979
- Acronym / sponsor ID
- LahoreGeneralH20
- Keywords
- Major Depressive Disorder, Treatment-Resistant Depression, Minocycline, Celecoxib, Fluoxetine, Adjunctive Drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 12 May 2022 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Minocycline | Experimental | Drug: MinocyclineParticipants received minocycline 100 mg orally twice daily as adjunctive treatment, along with fluoxetine 20-40 mg orally per day, for 12 weeks. |
| Group Celecoxib | Active comparator | Drug: CelecoxibParticipants received celecoxib 200 mg orally twice daily as adjunctive treatment, along with fluoxetine 20-40 mg orally per day, for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline 100 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks. | Drug | Group Minocycline |
| CelecoxibCelecoxib 200 mg orally twice daily was administered in addition to fluoxetine 20-40 mg/day for 12 weeks. | Drug | Group Celecoxib |
Primary outcome
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.
1 secondary outcome
Treatment Response Based on HAM-D Score
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhana Ashraf principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline and Celecoxib in people with Major Depressive Disorder (MDD) and Treatment-resistant Depression (TRD), run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAM-D) Score (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.