Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Minocycline
- Conditions
- Depression
- Sponsor
- Pakistan Institute of Living and Learning
- Enrollment
- 265
- Locations
- 4
- Primary Endpoint
- Hamilton Depression Scale scores
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
Minocycline with TAU
Intervention: Minocycline
Celecoxib with TAU
Intervention: Celecoxib
Minocycline and celecoxib with TAU
Intervention: Minocycline
Minocycline and celecoxib with TAU
Intervention: Celecoxib
Placebo with TAU
Intervention: Placebo
Outcomes
Primary Outcomes
Hamilton Depression Scale scores
Time Frame: 12 weeks