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Open Treatment of Minocycline in Geriatric Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659320
First Posted: August 7, 2012
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  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.

Condition Intervention
Depression Drug: Minocycline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Treatment of Minocycline in Geriatric Depression

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
    A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.


Enrollment: 16
Study Start Date: March 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline
Open label treatment using minocycline.
Drug: Minocycline
Minocycline 100 mg twice daily for 8 weeks

Detailed Description:
This research study will examine whether elderly depressed patients whose depressive symptoms do not respond satisfactorily to antidepressant therapy alone gain any benefit from taking minocycline alone or in addition to their antidepressants. 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. Elderly patients with depression who remain symptomatic after at least 6 weeks of treatment with an antidepressant medication reaching a therapeutic dosage will be recruited and receive minocycline augmentation for 8 weeks. They may or may not remain on their antidepressants based on their physicians' clinical recommendation. Response to treatment will be measured weekly during the first four weeks and every other week thereafter using rating scales of depressive symptoms, intellectual functions and side effects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659320


Locations
United States, New York
Institute of Geriatric Psychiatry
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: George S. Alexopoulos, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01659320     History of Changes
Other Study ID Numbers: 1005011034
P30MH085943-04 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2012
First Posted: August 7, 2012
Results First Submitted: February 17, 2017
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents