Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703363
• Other study ID #: MIN-BPD
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease
• Mood Disorders

Intervention

Drug:
• Minocycline

• Celecoxib

• Placebo

Locations

Country	Name	City	State
Pakistan	Abbasi Shaheed Hospital	Karachi	Sindh
Pakistan	Dow University of Health Sciences	Karachi	Sindh
Pakistan	Institute of Behavioural Sciences	Karachi	Sindh
Pakistan	Karwan-e-Hayat	Karachi	Sindh

Sponsors (6)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Abbasi Shaheed Hospital, Dow University of Health Sciences, Rawalpindi Medical College, Pakistan, Stanley Medical Research Institute, University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale scores		12 weeks