Minocycline and Aspirin in the Treatment of Bipolar Depression

NCT01429272 | Completed Phase 3 Results DMC

• 1 other identifier: LIBR 2011-002
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 3

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.

Conditions

Bipolar Disorder Depression

Keywords

Bipolar Disorder; Minocycline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Remission Rate

  Six weeks

Study Arms (2)

Placebo & Placebo

PLACEBO COMPARATOR

Placebo for minocycline \& placebo for aspirin

Drug: placebo

minocycline & aspirin

ACTIVE COMPARATOR

Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks

Drug: Minocycline; Drug: Aspirin

Interventions

Minocycline DRUG

100 mg po bid for 6 weeks

minocycline & aspirin

Aspirin DRUG

81 mg po bid for 6 weeks

minocycline & aspirin

placebo DRUG

placebo for minocycline and/or aspirin

Placebo & Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• Stanley Medical Research Institute: collaborator
• University of Oklahoma: collaborator

Study Sites (3)

University of Kansas Medical Center Research Institute

Wichita, Kansas, 67207, United States

Location

University of Oklahoma Department of Psychiatry

Tulsa, Oklahoma, 74135, United States

Location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136-3326, United States

Location

Related Publications (1)

• Savitz J, Preskorn S, Teague TK, Drevets D, Yates W, Drevets W. Minocycline and aspirin in the treatment of bipolar depression: a protocol for a proof-of-concept, randomised, double-blind, placebo-controlled, 2x2 clinical trial. BMJ Open. 2012 Feb 22;2(1):e000643. doi: 10.1136/bmjopen-2011-000643. Print 2012.

  PMID: 22357572 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder; cyclopia sequence

Interventions

Minocycline; Aspirin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives

Results Point of Contact

• Title: Jonathan Savitz; Principal Investigator
• Organization: Laureate Institute for Brain Research

jsavitz@laureateinstitute.org

918 502 5104

Study Officials

• Sheldon Preskorn, MD

  Laureate Institute for Brain Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 11, 2018
• Results First Posted: November 8, 2017

Record last verified: 2017-12

Locations

US (3)