Bipolar DisorderNCT02765100
Depression, Obesity and Inflammatory Markers
A study testing Minocycline in people with Bipolar Disorder and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to better understand the relationship between bipolar disorder, body weight, and inflammation in the body (N=180). People with bipolar depression (N = 50)will be offered a place in a pilot study looking to see if the antibiotic minocycline added to current psychiatric medications has an… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bipolar Disorder, Depression, Obesity
- What is being tested?
- Minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Bipolar Disorder and current depressive symptoms
- Hamilton Depression Scale score > 18
- Failed an adequate trial of at least one antidepressant or mood stabilizer of at least 4 weeks duration. Medication history will be recorded using the Antidepressant Treatment History Form
- 18 years or older
- Fluent in English or Arabic
- Have the capacity to understand the nature of the study and sign the written informed consent.
Who cannot join
- A current diagnosis of Schizophrenia or other psychotic disorder, or Dementia Alzheimer Type or related cognitive disorders.
- Principal diagnosis of Post-Traumatic Stress Disorder, Anorexia or Bulimia Nervosa, Obsessive-Compulsive Disorder. We define principal as the most pressing clinical problem.
- Pregnant or nursing
- Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder (defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
- Patients who currently meet criteria for Alcohol or other Substance-Related Dependence Disorder (with the exception of nicotine dependence) who require detoxification.
- Patients who are unable to read and write English or Arabic.
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- Patients having serious, unstable or terminal medical or neurologic illness that would compromise study participation (i.e., metastatic or advanced malignancy, chronic renal failure requiring dialysis, recent myocardial infarction or unstable angina, or "end stage" chronic obstructive pulmonary disease). People with common conditions such as hypertension, insulin dependent diabetes mellitus, asthma, compensated congestive heart failure, a malignancy in remission, treated hypothyroidism, or epilepsy will not be excluded from participation.
- Autoimmune disease or chronic inflammatory diseases such as psoriasis or Crohn's disease
- Chronic infection such as hepatitis B or C or HIV
- Elevated antinuclear antibody or rheumatoid factor
- Oral glucocorticoids in the past 6 months
- Methotrexate or NSAID use in the past two weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
The purpose of this study is to better understand the relationship between bipolar disorder, body weight, and inflammation in the body (N=180). People with bipolar depression (N = 50)will be offered a place in a pilot study looking to see if the antibiotic minocycline added to current psychiatric medications has an effect on mood. A separate consent form will be provided for the pilot study. Numerous studies have documented the presence of altered immune function and elevation of inflammatory markers in patients with depression. Studies suggest that major depression is accompanied by immune dysregulation and activation of the inflammatory response system. While a small number of studies have found elevated inflammatory markers in bipolar mania, very little has been reported about inflammation in bipolar depression, and none of these studies have addressed the relationship of inflammatory markers with obesity in bipolar disorder.
Read the detailed description
Aim 1 (N=180)will examine relationships between the levels of the inflammatory markers and current clinical state (depressed, manic or euthymic) with the hypothesis that Inflammatory markers will be higher in depression and mania relative to the euthymic state.
Aim 2 (N=180)will examine relationships between inflammatory markers and BMI in bipolar patients with the hypothesis that inflammatory markers will correlate positively with BMI.
Aim 3 (N=180)will examine the relationship between depression, obesity and inflammatory markers with the hypothesis that depressed (or manic) bipolar patients who are also obese will have higher inflammatory markers than either obese euthymic patients or non-obese depressed or manic patients.
Aim 4. (N=50) The pilot study will be to conduct a proof of concept add-on treatment study of the antibiotic minocycline for bipolar patients who are depressed, likely to be obese and likely to have elevated inflammatory markers and increased risk of heart disease. This is a proposal to conduct a 2-site trial of 50 subjects to examine the value of minocycline augmentation in bipolar depressed patients who are incompletely responsive to initial treatment with anti depressants and/or mood stabilizers. The investigators will compare two subgroups of depressed patients, those who have high (N=25) versus those who have low (N=25) levels of C-reactive protein (CRP).
- Conditions
- Bipolar Disorder, Depression, Obesity
- Being tested
- Minocycline
- Keywords
- Bipolar Disorder, Obesity, Depression
- Medical subject headings
- Bipolar Disorder, Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minocin
Minocycline 100 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Low CRP | Experimental | Subjects have CRP > 3 Receives: Drug: Minocycline |
| High CRP | Experimental | Subjects have CRP =/> 3 Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8
Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.
Measured: Baseline; week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2019
- Study completionOct 2019
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 Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar
- Responsible party
- Sponsor
- Investigators
- James H Kocsis, MD, Principal investigator, Weill CMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765100
- Sponsor's protocol ID
- 1406015184
- Status last verified
- Jun 2020
- First submitted
- 3 May 2016
- Last updated
- 1 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Obesity and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT02765100
- Acronym / sponsor ID
- 1406015184
- Conditions
- Bipolar Disorder, Depression, Obesity
- Keywords
- Bipolar Disorder, Obesity, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 1 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the relationship between bipolar disorder, body weight, and inflammation in the body (N=180). People with bipolar depression (N = 50)will be offered a place in a pilot study looking to see if the antibiotic minocycline added to current psychiatric medications has an effect on mood. A separate consent form will be provided for the pilot study. Numerous studies have documented the presence of altered immune function and elevation of inflammatory markers in patients with depression. Studies suggest that major depression is accompanied by immune dysregulation and activation of the inflammatory response system. While a small number of studies have found elevated inflammatory markers in bipolar mania, very little has been reported about inflammation in bipolar depression, and none of these studies have addressed the relationship of inflammatory markers with obesity in bipolar disorder.
Detailed description
Aim 1 (N=180)will examine relationships between the levels of the inflammatory markers and current clinical state (depressed, manic or euthymic) with the hypothesis that Inflammatory markers will be higher in depression and mania relative to the euthymic state.
Aim 2 (N=180)will examine relationships between inflammatory markers and BMI in bipolar patients with the hypothesis that inflammatory markers will correlate positively with BMI.
Aim 3 (N=180)will examine the relationship between depression, obesity and inflammatory markers with the hypothesis that depressed (or manic) bipolar patients who are also obese will have higher inflammatory markers than either obese euthymic patients or non-obese depressed or manic patients.
Aim 4. (N=50) The pilot study will be to conduct a proof of concept add-on treatment study of the antibiotic minocycline for bipolar patients who are depressed, likely to be obese and likely to have elevated inflammatory markers and increased risk of heart disease. This is a proposal to conduct a 2-site trial of 50 subjects to examine the value of minocycline augmentation in bipolar depressed patients who are incompletely responsive to initial treatment with anti depressants and/or mood stabilizers. The investigators will compare two subgroups of depressed patients, those who have high (N=25) versus those who have low (N=25) levels of C-reactive protein (CRP).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low CRP | Experimental | Drug: MinocyclineSubjects have CRP > 3 |
| High CRP | Experimental | Drug: MinocyclineSubjects have CRP =/> 3 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Bipolar Disorder and current depressive symptoms
- Hamilton Depression Scale score > 18
- Failed an adequate trial of at least one antidepressant or mood stabilizer of at least 4 weeks duration. Medication history will be recorded using the Antidepressant Treatment History Form
- 18 years or older
- Fluent in English or Arabic
Key exclusion criteria (12 listed)
- A current diagnosis of Schizophrenia or other psychotic disorder, or Dementia Alzheimer Type or related cognitive disorders.
- Principal diagnosis of Post-Traumatic Stress Disorder, Anorexia or Bulimia Nervosa, Obsessive-Compulsive Disorder. We define principal as the most pressing clinical problem.
- Pregnant or nursing
- Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder (defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
- Patients who currently meet criteria for Alcohol or other Substance-Related Dependence Disorder (with the exception of nicotine dependence) who require detoxification.
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 |
|---|---|---|
| MinocyclineAlso: MinocinMinocycline 100 mg twice a day | Drug | High CRP, Low CRP |
Primary outcome
Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8
Time frame: Baseline; week 8
Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared.
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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.
James H Kocsis, MD principal investigator
Weill CMC
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 Bipolar Disorder and 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 12 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 1 Jul 2020. 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 1 Jul 2020). 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?
Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8 (time frame: Baseline; week 8). 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 1 Jul 2020.