Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02703363

Enrollment

265

Registered

2016-03-09

Start date

2016-08-31

Completion date

2018-12-31

Last updated

2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression, Bipolar Disorder, Depression, Mood Disorders

Brief summary

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.

Interventions

DRUGMinocycline

DRUGCelecoxib

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Scale scores	12 weeks

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026