Adjunct Minocyline in Treatment-resistant Depression

Major Depressive Disorder Clinical Trial

— Mino-TRD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456948
• Other study ID #: 01EE1401F
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: August 7, 2020

Study information

• Verified date: October 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Drug:
• Minocycline
6 weeks 200mg/day Minocycline add-on
• Placebo
6 weeks Placebo add-on

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen	Aachen
Germany	Department of Psychiatry, Charité - Campus Benjamin Franklin	Berlin
Germany	Department of Psychiatry, Universitiy Hospital	Erlangen	Bavaria
Germany	Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt	Frankfurt
Germany	Department of Psychiatry, University Medical Center Göttingen	Göttingen	Lower Saxony
Germany	Heidelberg University Hospital, Department of Psychiatry	Heidelberg	Baden-Württemberg
Germany	Department of Psychiatry, LMU Munich	Munich	Bavaria
Germany	Max Planck Institute of Psychiatry	Munich	Bavaria
Germany	Department of Psychiatry, Universitiy Hospital	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)		6 weeks
Secondary	Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)		6 weeks
Secondary	HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)		6 weeks
Secondary	BDI-Scale (Beck Depression Inventory, Self Rating Scale)		6 weeks
Secondary	CGI-Scale (Clinical Global Impressions Scale)		6 weeks
Secondary	SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)		6 weeks
Secondary	Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells		6 weeks
Secondary	Protein levels of various inflammation-associated markers in patient sera		6 weeks