Adjunct Minocyline in Treatment-resistant Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Minocycline

• Registration Number: NCT02456948
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Primary Completion: 2020-08-07
• Study Completion: 2020-08-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo and standard antidepressant treatment
Minocycline	Minocycline	Minocycline and standard antidepressant treatment

Primary Outcome Measures

Name	Time	Method
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)	6 weeks
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
SCL-90-R (Symptom Checklist 90-R, Self 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

Trial Locations

Locations (8)

Department of Psychiatry, University Medical Center Göttingen; 🇩🇪 Göttingen, Lower Saxony, Germany

Department of Psychiatry, LMU Munich; 🇩🇪 Munich, Bavaria, Germany

Max Planck Institute of Psychiatry; 🇩🇪 Munich, Bavaria, Germany

Department of Psychiatry, Universitiy Hospital; 🇩🇪 Regensburg, Bavaria, Germany

Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen; 🇩🇪 Aachen, Germany

Heidelberg University Hospital, Department of Psychiatry; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt; 🇩🇪 Frankfurt, Germany

Department of Psychiatry, Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany