Minocycline and Aspirin in the Treatment of Bipolar Depression

Bipolar Disorder Depression Clinical Trial

— Minocycline  

Official title:

Minocycline and Aspirin in the Treatment of Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429272
• Other study ID #: LIBR 2011-002
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2011
• Last updated: December 13, 2017
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2017
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether minocycline and aspirin are effective in the treatment of depression in individuals with bipolar disorder.

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. These changes have been hypothesized to result from chronic inflammation, based partly on convergent evidence that proinflammatory cytokines are elevated in depressed patients with BD. 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 evaluate the efficacy of augmentation therapy with minocycline and/or aspirin for bipolar depression.

The investigators will test the hypothesis that compared with placebo, participants receiving minocycline and/ or aspirin will show a greater treatment response rate (defined as a >50% increase on the MADRS for the final two consecutive visits).

Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin and markers of inflammation (serum concentrations of IL-6 and CRP).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 or NOS) 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 Quick Inventory of Depressive Symptomatology (QID-C16) score >10. Subjects will provide written informed consent as approved by the Western Institutional Review Board.

Exclusion Criteria:

(a) Illness onset after 40 years of age; (b) serious risk of suicide; (c) current delusions or hallucinations sufficient to interfere with the capacity to provide informed consent; (d) current manic symptoms of sufficient severity to pose a substantial risk of the development of a manic episode; (e) current treatment with more than four psychotropic medications; (f) medical illness including hepatic impairment, renal dysfunction, bleeding diatheses, cerebrovascular disease, hypertension or diabetes mellitus that is inadequately controlled by diet and/or medication, or known active peptic ulcer disease; (g) abuse of drugs or alcohol within the preceding 6 months, or substance dependence within the last year; (h) daily alcoholic beverage consumption equivalent to >3 oz. of alcohol; (i) known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs; (j) current use of drugs that could increase the risks associated with aspirin or minocycline administration, (k) chronic infection, (l) use of antibiotics, (m) pregnant or nursing women, (n) asthma which in the opinion of the investigator would increase the likelihood of an asthmatic attack, and (o) regular use of steroidal or non-steroidal anti-inflammatory medications (occasional use of NSAIDS was allowed).

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Minocycline
100 mg po bid for 6 weeks
• Aspirin
81 mg po bid for 6 weeks
• placebo
placebo for minocycline and/or aspirin

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma
United States	University of Oklahoma Department of Psychiatry	Tulsa	Oklahoma
United States	University of Kansas Medical Center Research Institute	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.	Stanley Medical Research Institute, University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Response	Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.	Six weeks
Secondary	Remission Rate	Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.	Six weeks

External Links

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