Adjunct Minocyline in Treatment-resistant Depression (Mino-TRD)

Charité University Medicine Berlin

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo

Drug: Minocycline

Study type

Interventional

Funder types

Other

Identifiers

NCT02456948

01EE1401F

Details and patient eligibility

About

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).

Full 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.

Enrollment

168 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)