Bipolar Depression
Conditions
Keywords
Bipolar disorder, depression, minocycline, mood disorders, bipolar depression
Brief summary
The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.
Detailed description
Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only two treatments have been FDA-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug Administration (FDA) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. This study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. This study will also offer an option to participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate (NAA) levels in the brain, which are thought to be decreased in bipolar disorder.
Interventions
DRUGMinocycline
Minocycline 100 to 300mg per day for 8 weeks
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria for Bipolar I Disorder or Bipolar II disorder, depressed phase * A baseline score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) * Participants on mood stabilizer medication for at least two weeks prior to starting the study, and must remain on the treatment during the study * Able to understand English
Exclusion criteria
* DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type * Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) * Serious suicide or homicide risk * Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease * Clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before visit 1 * Drug/alcohol dependence within past 30 days, or current substance use disorder that requires detoxification * Current use of minocycline or history of anaphylactic reaction or intolerance to minocycline * Primary clinical diagnosis of antisocial or borderline personality disorder * Patients with metallic foreign bodies or claustrophobia will be excluded from the MRS component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) | baseline and week 8 | Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan | baseline and week 8 | Measured at baseline and week 8 |
| Changes in Young Mania Rating Scale (YMRS) | baseline and week 8 | Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania). |
Countries
United States
Participant flow
Recruitment details
Study procedures were conducted between June 2011 and June 2013 at the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai.
Participants by arm
| Arm | Count |
|---|---|
| Minocycline Minocycline 100 to 300mg per day for 8 weeks | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Minocycline |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 12.7 |
| Gender Female | 8 Participants |
| Gender Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Time frame: baseline and week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Minocycline | Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) | -14.6 units on a scale |
Secondary
Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan
Measured at baseline and week 8
Time frame: baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minocycline | Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan | 0.001 mmol/L | Standard Deviation 0.0022 |
Secondary
Changes in Young Mania Rating Scale (YMRS)
Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).
Time frame: baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minocycline | Changes in Young Mania Rating Scale (YMRS) | baseline | 1.8 units on a scale | Standard Deviation 2.3 |
| Minocycline | Changes in Young Mania Rating Scale (YMRS) | week 8 | 1.1 units on a scale | Standard Deviation 0.9 |