DepressionPhase 3NCT02703363

Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

A Phase 3 study testing Minocycline and Celecoxib in people with Depression and Bipolar Disorder, run by Pakistan Institute of Living and Learning at 4 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Bipolar Disorder, Bipolar Depression
What is being tested?: Minocycline and Celecoxib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 265 participants
Where: 4 sitesPakistan
Study dates: Aug 2016to Dec 2018
Phase: Phase 3
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;
Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder;
Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18);
Competent and willing to give informed consent;
Taking the current medication for a minimum of 4 week prior to baseline;
Able to take oral medication;
If female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.

Who cannot join

Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis);
Prior history of intolerance to any of the tetracyclines or NSAIDs;
Concomitant penicillin therapy;
Concomitant anticoagulant therapy;
Presence of a seizure disorder;
Currently taking other antibiotics, other NSAIDs, acetazolamide, or methotrexate;

Show all 12Show fewer

Any change of psychotropic medications within the previous 4 weeks;
Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-5 criteria;
Pregnant or breast-feeding;
Presence of primary psychotic disorder;
Serious risk of suicide;
Current three or more manic/hypomanic symptoms.

Trial locations and contacts

4 sites in 1 country.

Pakistan4 sites

Dow University of Health Sciences
Karachi, Sindh, 69000
Institute of Behavioural Sciences
Karachi, Sindh, 72000
Karwan-e-Hayat
Karachi, Sindh, 72000
Abbasi Shaheed Hospital
Karachi, Sindh

Other trials in Pakistan

About this study

Official title: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial

Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. In this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in patients experiencing a depressive phase of bipolar I or II disorder. The investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.

Conditions: Depression, Bipolar Disorder, Bipolar Depression, Mood Disorders
Being tested: Minocycline, Celecoxib, Placebo
Medical subject headings: Depression, Bipolar Disorder, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MinocyclineDrug
CelecoxibDrug
PlaceboDrug

Study groups in NCT02703363
Study group	Role	What they receive
Minocycline with TAU	Experimental	Not described Receives: Drug: Minocycline
Celecoxib with TAU	Experimental	Not described Receives: Drug: Celecoxib
Minocycline and celecoxib with TAU	Experimental	Not described Receives: Drug: Minocycline; Drug: Celecoxib
Placebo with TAU	Active comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Scale scores
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Dec 2018

First posted9 Mar 2016 (estimated)
Study startAug 2016
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02703363
Sponsor's protocol ID: MIN-BPD
Status last verified: Aug 2019
First submitted: 4 Mar 2016
Last updated: 5 Aug 2019
Results posted: No

Publications

Husain MI, Chaudhry IB, Khoso AB, Husain MO, Hodsoll J, Ansari MA, Naqvi HA, Minhas FA, Carvalho AF, Meyer JH, Deakin B, Mulsant BH, Husain N, Young AH. Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):515-527. doi: 10.1016/S2215-0366(20)30138-3. Epub 2020 May 20.
PubMed 32445690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
ClinicalTrials.gov ID: NCT02703363
Acronym / sponsor ID: MIN-BPD
Conditions: Depression, Bipolar Disorder, Bipolar Depression, Mood Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: Pakistan Institute of Living and LearningUniversity, hospital or other
Collaborators: Dow University of Health Sciences, Abbasi Shaheed Hospital, Rawalpindi Medical College, Pakistan, University of Manchester, Stanley Medical Research Institute
Study start: Aug 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 9 Mar 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Minocycline with TAU	Experimental	Drug: Minocycline
Celecoxib with TAU	Experimental	Drug: Celecoxib
Minocycline and celecoxib with TAU	Experimental	Drug: Minocycline, Drug: Celecoxib
Placebo with TAU	Active comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients aged 18-65 years;
Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder;
Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18);
Competent and willing to give informed consent;
Taking the current medication for a minimum of 4 week prior to baseline;

Key exclusion criteria (12 listed)

Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis);
Prior history of intolerance to any of the tetracyclines or NSAIDs;
Concomitant penicillin therapy;
Concomitant anticoagulant therapy;
Presence of a seizure disorder;

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
Minocycline	Drug	Minocycline and celecoxib with TAU, Minocycline with TAU
Celecoxib	Drug	Celecoxib with TAU, Minocycline and celecoxib with TAU
Placebo	Drug	Placebo with TAU

Primary outcome

Hamilton Depression Scale scores
Time frame: 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 5 Aug 2019.
Derived from this study: PubMed 32445690Husain MI, Chaudhry IB, Khoso AB, Husain MO, Hodsoll J, Ansari MA, Naqvi HA, Minhas FA, Carvalho AF, Meyer JH, Deakin B, Mulsant BH, Husain N, Young AH. Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):515-527. doi: 10.1016/S2215-0366(20)30138-3. Epub 2020 May 20.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minocycline and Celecoxib in people with Depression and Bipolar Disorder, run by Pakistan Institute of Living and Learning at 4 sites 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 7 inclusion and 12 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hamilton Depression Scale scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02703363, which also lists 1 linked publication.

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 5 Aug 2019.