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

October 16, 2020 updated by: Isabella Heuser, Charite University, Berlin, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
      • Berlin, Germany, 12203
        • Department of Psychiatry, Charité - Campus Benjamin Franklin
      • Frankfurt, Germany
        • Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69115
        • Heidelberg University Hospital, Department of Psychiatry
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Department of Psychiatry, Universitiy Hospital
      • Munich, Bavaria, Germany, 80804
        • Max Planck Institute of Psychiatry
      • Munich, Bavaria, Germany, 80336
        • Department of Psychiatry, LMU Munich
      • Regensburg, Bavaria, Germany, 93053
        • Department of Psychiatry, Universitiy Hospital
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Department of Psychiatry, University Medical Center Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minocycline
Minocycline and standard antidepressant treatment
Drug: Minocycline
6 weeks 200mg/day Minocycline add-on
Other Names:
  • Minocin
  • Solodyn
Placebo Comparator: Placebo
Placebo and standard antidepressant treatment
Drug: Placebo
6 weeks Placebo add-on
Other Names:
  • Sugar pills, mimics Minocycline tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Isabella Heuser, MD, PhD, Chair: Department of Psychiatry Charité - Campus Benjamn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

August 7, 2020

Study Completion (Actual)

August 7, 2020

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01EE1401F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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