Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02703363
• Date of registration: 04/03/2016
• Prospective Registration: Yes
• Primary sponsor: Pakistan Institute of Living and Learning
• Public title: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression
• Scientific title: Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
• Date of first enrolment: August 2016
• Target sample size: 265
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02703363
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Pakistan

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mood Disorders

Bipolar Depression

Depression

Bipolar Disorder

Intervention(s)

Drug: Celecoxib

Drug: Placebo

Drug: Minocycline

Primary Outcome(s)

Hamilton Depression Scale scores [Time Frame: 12 weeks]

Secondary ID(s)

MIN-BPD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Manchester

Rawalpindi Medical College, Pakistan

Dow University of Health Sciences

Abbasi Shaheed Hospital

Stanley Medical Research Institute