DepressionNCT01659320
Open Treatment of Minocycline in Geriatric Depression
A study testing Minocycline in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Depression
- What is being tested?
- Minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Participants must be 55 years old or older (female patients must be postmenopausal);
- 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);
- Severity of depression: 17-item Hamilton Depression Rating Scale(HRSD)>14;
- 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).
- Fluency in English
- Capacity to provide informed consent.
Who cannot join
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- 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);
- Axis II diagnosis of antisocial personality disorder, schizotypal or severe borderline personality, mental retardation and pervasive developmental disorder (DSM-IV);
- Dementia of more than mild severity (MMSE < 20);
- History of psychiatric disorders such as psychotic depression, primary psychotic disorder
- 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;
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- 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;
- History of intolerance to minocycline or other tetracyclines; use of concomitant drugs that may provide reason to believe that minocycline is contraindicated;
- Patients on anticoagulants (except low-dose aspirin); patients on ergot alkaloids
- Patients on MAOIs;
- 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).
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion;
- Inability to speak English;
- Corrected visual acuity < 20/70;
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Geriatric Psychiatry
White Plains, New York, 10605
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Minocycline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline 100 mg twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Open label treatment using minocycline. Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- George S. Alexopoulos, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659320
- Sponsor's protocol ID
- 1005011034
- Other IDs
- P30MH085943-04
- Status last verified
- Apr 2017
- First submitted
- 2 Aug 2012
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Treatment of Minocycline in Geriatric Depression
- ClinicalTrials.gov ID
- NCT01659320
- Acronym / sponsor ID
- 1005011034
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineOpen label treatment using minocycline. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Participants must be 55 years old or older (female patients must be postmenopausal);
- 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);
- Severity of depression: 17-item Hamilton Depression Rating Scale(HRSD)>14;
- 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).
- Fluency in English
Key exclusion criteria (14 listed)
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- 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);
- Axis II diagnosis of antisocial personality disorder, schizotypal or severe borderline personality, mental retardation and pervasive developmental disorder (DSM-IV);
- Dementia of more than mild severity (MMSE < 20);
- History of psychiatric disorders such as psychotic depression, primary psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline 100 mg twice daily for 8 weeks | Drug | Minocycline |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George S. Alexopoulos, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (MADRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.