Major Depressive Disorder
Conditions
Keywords
treatment resistant depression, inflammation, microglia, minocycline
Brief summary
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).
Detailed description
This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.
Interventions
DRUGMinocycline
6 weeks 200mg/day Minocycline add-on
DRUGPlacebo
6 weeks Placebo add-on
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * male or female * between age 18 and 75 * BMI between 18 and 40 inclusive * Non-lactating, non-pregnant females of child-bearing potential must be willing to use an effective contraceptive method * All participants must fulfil diagnostic criteria of moderate or severe MDD according to the DSM-5. * HAMD-17 score of at least 16 points at baseline and a * CGI-S score of at least 4. * AD-ST must have been administered at a sufficient dose for at least 6 weeks in the current episode and at a * stable regimen for at least 14 days prior to baseline. * Dose and duration of AD-ST must be verifiable
Exclusion criteria
* prevalence of neurodegenerative disorder * prevalence of any neurological disorder that caused the depressive symptoms * prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease * prevalence of any other psychiatric disorder that better explains the presence of depressive symptoms * Improvement by more than 50% in HAMD-17 score during the last 14 days prior to baseline * pregnant or nursing women will not be allowed. * substance or alcohol abuse within past 6 months or positive urine drug screening * abnormal thyroid function (euthyroid at presentation), liver or kidney dysfunction * history of autoimmune disease (except Hashimotos thyroiditis) * clinically significant laboratory abnormalities (outside normal ranges) * current medication with anti-inflammatory substances (NSAIDs, corticosteroids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response as per MADRS (Montgomery-Åsberg Depression Rating Scale) | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HAM-D-17-Scale (17-item Hamilton Depression Rating Scale) | 6 weeks |
| BDI-Scale (Beck Depression Inventory, Self Rating Scale) | 6 weeks |
| CGI-Scale (Clinical Global Impressions Scale) | 6 weeks |
| Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale) | 6 weeks |
| Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells | 6 weeks |
| Protein levels of various inflammation-associated markers in patient sera | 6 weeks |
| SCL-90-R (Symptom Checklist 90-R, Self Rating Scale) | 6 weeks |
Countries
Germany
Outcome results
None listed