Phase 4
Completed N=20
Minocycline for Bipolar Depression
Source: ClinicalTrials.gov NCT01514422 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) — -14.6 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) |
-14.6 | — |
| SECONDARY Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan |
0.001 | — |
| SECONDARY Changes in Young Mania Rating Scale (YMRS) |
1.8; 1.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01514422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.