White Plains, New York 10605

  • Depression

Purpose:

This research study will examine whether elderly depressed patients whose depressive symptoms do not respond satisfactorily to therapy with a mood stabilizer or antidepressant alone gain any benefit from taking minocycline alone or in addition to their antidepressant or mood stabilizer medication. Minocycline is a commonly used antibiotic medication with anti-inflammatory properties. It is hoped that information gained from this study will help the investigators better understand the role of inflammation in depression, and whether decreasing inflammation will lead to improvement in the symptoms of depression and cognitive function.


Criteria:

Inclusion Criteria: 1. Age: Participants must be 55 years old or older (female patients must be postmenopausal); 2. Diagnosis: Major depression, either unipolar or bipolar without psychotic features (by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria and assessed on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID); 3. Severity of depression: 17-item Hamilton Depression Rating Scale(HRSD)>14; 4. Failure to achieve substantial improvement of depressive symptoms (entry HDRS>14) after at least 6 weeks of treatment with a mood stabilizer or an antidepressant (SSRI, SNRI, or TCA) reaching therapeutic dosages (daily dose of at least: fluoxetine 20 mg, sertraline 150 mg, paroxetine 20 mg, citalopram 20 mg, escitalopram 10 mg, venlafaxine 150 mg, duloxetine 60 mg). 5. Fluency in English 6. Capacity to provide informed consent. Exclusion Criteria: 1. High suicide risk, i.e. intent or plan to attempt suicide in near future; 2. Presence of any current Axis I psychiatric disorder (other than unipolar or bipolar major depression or generalized anxiety disorder) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry); 3. Axis II diagnosis of antisocial personality disorder, schizotypal or severe borderline personality, mental retardation and pervasive developmental disorder (DSM-IV); 4. Dementia of more than mild severity (MMSE < 20); 5. History of psychiatric disorders such as psychotic depression, primary psychotic disorder 6. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry, advanced autoimmune deficiency, or "end stage" chronic obstructive pulmonary disease; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal; 7. Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. Multiple Sclerosis; 8. History of intolerance to minocycline or other tetracyclines; use of concomitant drugs that may provide reason to believe that minocycline is contraindicated; 9. Patients on anticoagulants (except low-dose aspirin); patients on ergot alkaloids 10. Patients on MAOIs; 11. Patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: Antidepressants, mood stabilizers, and low and stable doses of opiates and non-benzodiazepine hypnotics, e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg). 12. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion; 13. Inability to speak English; 14. Corrected visual acuity < 20/70;


Study is Available At:


Original ID:

P30 MH085943-04


NCT ID:

NCT01659320


Secondary ID:


Study Acronym:


Brief Title:

Open Treatment of Minocycline in Geriatric Depression


Official Title:


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

55 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:George S. Alexopoulos, M.D.
Principal Investigator
Weill Medical College of Cornell University
Primary Contact:Bryony Lucas
914-682-9100 ext. 2497
914-682-9100
brl2013@med.cornell.edu

Study Dates

Start Date:March 2012
Completion Date:April 2015
Completion Type:Anticipated
Primary Completion Date:April 2015
Primary Completion Type:Anticipated
Verification Date:December 2014
Last Changed Date:December 18, 2014
First Received Date:August 2, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depression
Time Frame:8 weeks
Safety Issues:False
Description:The primary objective of this study is to provide hypothesis generation data that may later be tested through a placebo controlled trial. Accordingly, we will examine whether minocycline alone or as an augmenting agent of antidepressants or mood stabiliz

Study Interventions

Intervention Type:Drug
Name:Minocycline
Description:Minocycline 100 mg twice daily for 8 weeks
Arm Name:Intervention

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention
Description:Open label treatment using minocycline.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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