Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

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.

Conditions

• Depression
• Bipolar Disorder
• Bipolar Depression
• Mood Disorders

Interventions

DRUG

Minocycline

DRUG

Celecoxib

DRUG

Placebo

Sponsors & Collaborators

• Dow University of Health Sciences

  collaborator OTHER

• Abbasi Shaheed Hospital

  collaborator OTHER

• Rawalpindi Medical College, Pakistan

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Stanley Medical Research Institute

  collaborator OTHER

• Pakistan Institute of Living and Learning

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Pakistan

Study Locations