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OpenTrials
Completed

NCT Number: NCT02703363

Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

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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Key information

Conditions

Depression Behavior Behavioral Symptoms Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abbasi Shaheed Hospital, Karachi, Sindh, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minocycline

Drug

Celecoxib

Drug

Placebo

Drug

Primary outcomes

  1. Hamilton Depression Scale scores

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Abbasi Shaheed Hospital
  • Dow University of Health Sciences
  • Rawalpindi Medical College, Pakistan
  • Stanley Medical Research Institute
  • University of Manchester

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2016
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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