Minocycline and Aspirin in the Treatment of Bipolar Depression
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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 |
- 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 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo
placebo for minocycline and/or aspirin
|
| Placebo Comparator: placebo & minocycline |
Drug: Minocycline
100 mg po bid for 6 weeks
Drug: placebo
placebo for minocycline and/or aspirin
|
| Placebo Comparator: placebo & aspirin |
Drug: Aspirin
81 mg po bid for 6 weeks
Drug: placebo
placebo for minocycline and/or aspirin
|
| Active Comparator: minocycline & aspirin |
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 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- inability to provide informed consent;
- age of onset of BD>40 years;
- serious risk of suicide;
- current delusions or hallucinations sufficient to interfere with the capacity to provide informed consent;
- 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)];
- 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;
- abuse of drugs or alcohol within the preceding 6 months, or substance dependence within the last 5 years;
- daily alcoholic beverage consumption equivalent to >3 oz of alcohol;
- asthma or known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs;
- 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;
- known HIV or other chronic infection including, but not limited to viral hepatitis.
- Pregnant or nursing women, and women who are attempting to conceive during the 8 week study period, will also be excluded.
Contacts and Locations| Contact: Shelly Hopper, RN | 918-502-5100 | shopper@laureateinstitute.org |
| United States, Kansas | |
| University of Kansas Medical Center Research Institute | Recruiting |
| Wichita, Kansas, United States, 67207 | |
| Principal Investigator: Sheldon Preskorn, M.D. | |
| United States, Oklahoma | |
| Laureate Institute for Brain Research | Recruiting |
| Tulsa, Oklahoma, United States, 74136-3326 | |
| Principal Investigator: Wayne C Drevets, M.D. | |
| 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: | November 27, 2012 |
| 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 Mood Disorders Mental Disorders Behavioral Symptoms Aspirin Minocycline Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013