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Minocycline and Aspirin in the Treatment of Bipolar Depression (Minocycline)

Primary Purpose

Bipolar Disorder Depression

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Minocycline

Aspirin

placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder Depression focused on measuring Bipolar Disorder, Minocycline

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of Kansas Medical Center Research Institute
University of Oklahoma Department of Psychiatry
Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo & Placebo

minocycline & aspirin

Arm Description

Placebo for minocycline & placebo for aspirin

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

Outcomes

Primary Outcome Measures

Treatment Response

Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.

Secondary Outcome Measures

Remission Rate

Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.

Full Information

NCT ID

NCT01429272

First Posted

September 2, 2011

Last Updated

December 13, 2017

Sponsor

Laureate Institute for Brain Research, Inc.

Collaborators

Stanley Medical Research Institute, University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT01429272

Brief Title

Minocycline and Aspirin in the Treatment of Bipolar Depression

Acronym

Minocycline

Official Title

Minocycline and Aspirin in the Treatment of Bipolar Depression

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laureate Institute for Brain Research, Inc.

Collaborators

Stanley Medical Research Institute, University of Oklahoma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder Depression

Keywords

Bipolar Disorder, Minocycline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo & Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for minocycline & placebo for aspirin

Arm Title

minocycline & aspirin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Minocycline

Intervention Description

100 mg po bid for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

81 mg po bid for 6 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo for minocycline and/or aspirin

Primary Outcome Measure Information:

Title

Treatment Response

Description

Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

Remission Rate

Description

Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.

Time Frame

Six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheldon Preskorn, MD

Organizational Affiliation

Laureate Institute for Brain Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center Research Institute

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

University of Oklahoma Department of Psychiatry

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Laureate Institute for Brain Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136-3326

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22357572

Citation

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.

Results Reference

derived

Links:

URL

http://www.laureateinstitute.org/

Description

Related Info

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Minocycline and Aspirin in the Treatment of Bipolar Depression

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