Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

NCT02703363 | Completed Phase 3

• 1 other identifier: MIN-BPD
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale scores

  12 weeks

Study Arms (4)

Minocycline with TAU

EXPERIMENTAL

Drug: Minocycline

Celecoxib with TAU

EXPERIMENTAL

Drug: Celecoxib

Minocycline and celecoxib with TAU

EXPERIMENTAL

Drug: Minocycline; Drug: Celecoxib

Placebo with TAU

ACTIVE COMPARATOR

Drug: Placebo

Interventions

Minocycline DRUG

Minocycline and celecoxib with TAU; Minocycline with TAU

Celecoxib DRUG

Celecoxib with TAU; Minocycline and celecoxib with TAU

Placebo DRUG

Placebo with TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Dow University of Health Sciences: collaborator
• Abbasi Shaheed Hospital: collaborator
• Rawalpindi Medical College, Pakistan: collaborator
• University of Manchester: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (4)

Dow University of Health Sciences

Karachi, Sindh, 69000, Pakistan

Location

Institute of Behavioural Sciences

Karachi, Sindh, 72000, Pakistan

Location

Karwan-e-Hayat

Karachi, Sindh, 72000, Pakistan

Location

Abbasi Shaheed Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Husain MI, Chaudhry IB, Khoso AB, Husain MO, Hodsoll J, Ansari MA, Naqvi HA, Minhas FA, Carvalho AF, Meyer JH, Deakin B, Mulsant BH, Husain N, Young AH. Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):515-527. doi: 10.1016/S2215-0366(20)30138-3. Epub 2020 May 20.

  PMID: 32445690 DERIVED

MeSH Terms

Conditions

Depression; Bipolar Disorder; Mood Disorders

Interventions

Minocycline; Celecoxib

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

PA (4)