Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01403662
• Date of registration: 18/07/2011
• Primary sponsor: University Health Network, Toronto
• Public title: Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression
• Scientific title: A Pilot, Open-label, 8-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Minocycline for the Treatment of Bipolar Depression
• Date of first enrolment: July 2011
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01403662
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Joanna K Soczynska, HBSc, PhD Candidate

• Name: Roger S McIntyre, MD, FRCPC
• Affiliation: University Health Network, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of bipolar I or II disorder

- Meets criteria for a current major depressive episode

- A score of >= 20 on the HAMD-17 at the time of enrollment and at baseline

- Episode duration will be greater than 4 weeks but not longer than 12 months.

Exclusion Criteria:

- Insufficiently responding to >2 treatment strategies FDA/Health
Canada-approved/guideline recommended for bipolar depression

- Acute manic or mixed episode

- An Axis I psychiatric disorder requiring primary clinical attention

- Clinically significant medical illness

- Treatment with minocycline or ß-lactam antibiotics in the preceding 6 months

- Hypersensitivity to minocycline or any other tetracycline

- Physical injury requiring medical treatment or surgery in the last 6 months

- Pregnant or breast-feeding

- Inability to provide written informed consent.



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

Health Condition(s) or Problem(s) studied

Bipolar Depression

Bipolar Disorder

Bipolar I Depression

Bipolar II Depression

Intervention(s)

Drug: Minocycline

Primary Outcome(s)

Change from baseline to week 8 on the Montgomery Asberg Depression Rating Scale (MADRS) [Time Frame: Baseline, Week 1, 2, 4, 6, 8]

Secondary Outcome(s)

Change from baseline to week 8 in concentrations of pro-and anti-inflammatory cytokines (i.e. TNFa, IL-1ß, IL-2, IL-6, IL8, IFN?, IL-4, IL-5, IL-10) [Time Frame: Baseline, Week 8]

Change from baseline to week 8 in the in neurocognitive function [Time Frame: Baseline, Week 8]

Change from baseline to week 8 on the Clinical Global Impression (CGI) Rating Scale [Time Frame: Baseline, Week 1, 2, 4, 6, 8]

Change from baseline to week 8 on the Hamilton Depression Rating Scale 17-item (HAMD-17) [Time Frame: Baseline, Week 1, 2, 4, 6, 8]

Change from baseline to week 8 on the Somatic Symptom Inventory (SSI) [Time Frame: Baseline, Week 8]

Monitoring of Side-effects from baseline to week 8 with the Toronto Side Effect Scale (TSES) [Time Frame: Week 1, 2, 4, 6, 8]

Monitoring of suicide severity from baseline to week 8 with the Columbia Suicide Severity Rating Scale (C-SSRS). [Time Frame: Baseline, Week 1, 2, 4, 6, 8]

Secondary ID(s)

3420337

Source(s) of Monetary Support

Please refer to primary and secondary sponsors