Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Last updated: August 2, 2019
Sponsor: Pakistan Institute of Living and Learning
Overall Status: Completed

Phase

3

Condition

Bipolar Disorder

Depression (Treatment-resistant)

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT02703363
MIN-BPD
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Patients aged 18-65 years;

  • Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder andcurrent 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 monthlypregnancy tests.

Exclusion

Exclusion Criteria:

  • Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatologicaldisorders 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 thelast 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.

Study Design

Total Participants: 265
Study Start date:
August 01, 2016
Estimated Completion Date:
December 31, 2018

Connect with a study center

  • Abbasi Shaheed Hospital

    Karachi, Sindh
    Pakistan

    Site Not Available

  • Dow University of Health Sciences

    Karachi, Sindh 69000
    Pakistan

    Site Not Available

  • Institute of Behavioural Sciences

    Karachi, Sindh 72000
    Pakistan

    Site Not Available

  • Karwan-e-Hayat

    Karachi, Sindh 72000
    Pakistan

    Site Not Available

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