Clinical trial NCT02703363: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression
Official title: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Bipolar Disorder
Bipolar Depression
Mood Disorders
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Dow University of Health Sciences
name: Abbasi Shaheed Hospital
name: Rawalpindi Medical College, Pakistan
name: University of Manchester
name: Stanley Medical Research Institute
First posted: 2016-03-09
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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;
* Serious risk of suicide;
* Current three or more manic/hypomanic symptoms.

Primary outcomes:
measure: Hamilton Depression Scale scores
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Institute of Behavioural Sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Karwan-e-Hayat
state: Sindh
city: Karachi
country: Pakistan
facility: Abbasi Shaheed Hospital
state: Sindh
Study officials:
References:
citation: 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.