NCT02456948

Adjunct Minocyline in Treatment-resistant Depression

A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Minocycline	6 weeks 200mg/day Minocycline add-on
DRUG	Placebo	6 weeks Placebo add-on

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-08-07
• Completion: 2020-08-07
• First posted: 2015-05-29
• Last updated: 2020-10-19

Locations

9 sites across 1 country: Germany