Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression Bipolar Disorder Bipolar Depression Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Minocycline with TAU

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

Celecoxib with TAU

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Minocycline and celecoxib with TAU

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

Celecoxib

Intervention Type DRUG

Placebo with TAU

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Minocycline

Intervention Type DRUG

Celecoxib

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No