Minocycline and Aspirin in the Treatment of Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Laureate Institute for Brain Research, Inc.
Sponsor:
Collaborators:
Stanley Medical Research Institute
University of Oklahoma
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier:
NCT01429272
First received: September 2, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Bipolar Disorder Depression
Drug: Minocycline
Drug: Aspirin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minocycline and Aspirin in the Treatment of Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Laureate Institute for Brain Research, Inc.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Depression symptom severity rating scale


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo & Placebo
Placebo for minocycline & placebo for aspirin
Drug: placebo
placebo for minocycline and/or aspirin
Active Comparator: minocycline & aspirin
Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks
Drug: Minocycline
100 mg po bid for 6 weeks
Drug: Aspirin
81 mg po bid for 6 weeks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One hundred and twenty male or female outpatients between 18 and 65 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429272

Contacts
Contact: Megan Cole, RN 918-502-5179 mcole@laureateinstitute.org

Locations
United States, Kansas
University of Kansas Medical Center Research Institute Recruiting
Wichita, Kansas, United States, 67207
Contact: Sheldon Preskorn, MD    316-293-1833      
Principal Investigator: Sheldon Preskorn, M.D.         
United States, Oklahoma
Laureate Institute for Brain Research Recruiting
Tulsa, Oklahoma, United States, 74136-3326
Contact: Megan Cole, RN    918-502-5155      
Principal Investigator: Sheldon Preskorn, M.D.         
University of Oklahoma Department of Psychiatry Recruiting
Tulsa, Oklahoma, United States, 74135
Contact: Ondria Gleason, MD    918-660-3118      
Principal Investigator: Ondria Gleason, MD         
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Stanley Medical Research Institute
University of Oklahoma
Investigators
Principal Investigator: Sheldon Preskorn, MD Laureate Institute for Brain Research, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT01429272     History of Changes
Other Study ID Numbers: LIBR 2011-002
Study First Received: September 2, 2011
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Laureate Institute for Brain Research, Inc.:
Bipolar Disorder
Minocycline

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Aspirin
Minocycline
Analgesics
Analgesics, Non-Narcotic
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on October 20, 2014