Status:
COMPLETED
Minocycline and Aspirin in the Treatment of Bipolar Depression
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Collaborating Sponsors:
Stanley Medical Research Institute
University of Oklahoma
Conditions:
Bipolar Disorder Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
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 m...
Eligibility Criteria
Inclusion
- 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
- (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).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01429272
Start Date
September 1 2011
End Date
September 1 2015
Last Update
January 11 2018
Active Locations (3)
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1
University of Kansas Medical Center Research Institute
Wichita, Kansas, United States, 67207
2
University of Oklahoma Department of Psychiatry
Tulsa, Oklahoma, United States, 74135
3
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136-3326