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Minocycline and Aspirin in the Treatment of Bipolar Depression

Information source: Laureate Institute for Brain Research, Inc.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder Depression

Intervention: Minocycline (Drug); Aspirin (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Laureate Institute for Brain Research, Inc.

Official(s) and/or principal investigator(s):
Sheldon Preskorn, MD, Principal Investigator, Affiliation: Laureate Institute for Brain Research, Inc.

Overall contact:
Shelly Hopper, RN, Phone: 918-502-5100, Email: shopper@laureateinstitute.org

Summary

The purpose of this study is to determine whether Minocycline and aspirin are effective in the treatment of depression in Bipolar patients.

Clinical Details

Official title: Minocycline and Aspirin in the Treatment of Bipolar Depression

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Montgomery-Asberg Depression Rating Scale

Detailed description: Abstract:

New medication classes are needed to improve treatment effectiveness in the depressed phase of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling, demyelination, and glial and neuronal cell loss (73). These changes have been hypothesized to result from chronic inflammation (45), based partly on convergent evidence that proinflammatory cytokines are elevated in depressed patients with BD (34, 12). The principal aims of the proposed research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized, double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.

Specific Aims Specific Aim 1: To test the hypothesis that augmentative treatment with minocycline and/ or aspirin will improve depression ratings to a greater extent than placebo.

Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin and markers of inflammation (serum concentrations of IL-6 and CRP, and IL-6 mRNA expression in peripheral blood monocytes (PBM). The investigators will test the hypotheses that: a) minocycline treatment will reduce inflammation to a greater extent than placebo; b) during minocycline treatment the change in inflammatory cytokine expression will correlate with the change in depression ratings; c) the baseline elevation of inflammatory markers will predict greater antidepressant response to minocycline.

Eligibility

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- One hundred and twenty male or female outpatients between 18 and 59 years of age, who

meet DSM-IV-TR criteria for BD (type I or II) and for a current major depressive episode will be recruited. The depressive syndrome must have been present for at least 4 weeks and the minimum threshold for depression severity will be set at a 17-item HAM-D score >10. Subjects will provide written informed consent as approved by the Western Institutional Review Board.

Exclusion Criteria:

1. inability to provide informed consent;

2. age of onset of BD>40 years;

3. serious risk of suicide;

4. current delusions or hallucinations sufficient to interfere with the capacity to provide informed consent;

5. current manic symptoms [depressed BD patients with concurrent manic symptoms have been found to be more likely to experience adverse reactions in antidepressant treatment trials (23)];

6. medical illness including as hepatic impairment, renal dysfunction, bleeding diatheses (e. g., hemophilia), known cerebrovascular disease or heart disease, hypertension that is inadequately controlled by medication, or known peptic ulcer disease;

7. abuse of drugs or alcohol within the preceding 6 months, or substance dependence within the last 5 years;

8. daily alcoholic beverage consumption equivalent to >3 oz of alcohol;

9. asthma or known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs;

10. current use of drugs that could increase the risks associated with aspirin or minocycline administration, namely other antibiotic medications, other NSAIDs or anticoagulants (e. g., warfarin), acetazolamide, or methotrexate;

11. known HIV or other chronic infection including, but not limited to viral hepatitis.

12. Pregnant or nursing women, and women who are attempting to conceive during the 8 week study period, will also be excluded.

Locations and Contacts

Shelly Hopper, RN, Phone: 918-502-5100, Email: shopper@laureateinstitute.org

University of Kansas Medical Center Research Institute, Wichita, Kansas 67207, United States; Recruiting
Sheldon Preskorn, M.D., Principal Investigator

Laureate Institute for Brain Research, Tulsa, Oklahoma 74136-3326, United States; Recruiting
Wayne C Drevets, M.D., Principal Investigator

Additional Information

Starting date: September 2011
Last updated: November 27, 2012

Page last updated: February 07, 2013

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