Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Pakistan Institute of Living and Learning265 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

265

Conditions

Depression Bipolar Disorder Bipolar Depression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (4)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Institute of Behavioural Sciences

Karachi, Sindh, Pakistan

Karwan-e-Hayat

Karachi, Sindh, Pakistan

Abbasi Shaheed Hospital

Karachi, Sindh, Pakistan

Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes