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Trial record 1 of 1 for:    NCT02456948
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Adjunct Minocyline in Treatment-resistant Depression (Mino-TRD)

This study is currently recruiting participants.
Verified July 2017 by Isabella Heuser, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT02456948
First Posted: May 29, 2015
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Isabella Heuser, Charite University, Berlin, Germany
  Purpose
This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment with es-/citalopram, venlafaxine or mirtazapine monotherapy (AD-ST), for patients with unipolar major depressive disorder (MDD).

Condition Intervention Phase
Major Depressive Disorder Drug: Minocycline Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)

Resource links provided by NLM:


Further study details as provided by Isabella Heuser, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Response as per MADRS (Montgomery-Åsberg Depression Rating Scale) [ Time Frame: 6 weeks ]

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

Estimated Enrollment: 160
Study Start Date: December 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline
Minocycline and standard antidepressant treatment (es-/citalopram, venlafaxine or mirtazapine monotherapy)
Drug: Minocycline
6 weeks 200mg/day Minocycline add-on
Other Names:
  • Solodyn
  • Minocin
Placebo Comparator: Placebo
Placebo and standard antidepressant treatment (es-/citalopram, venlafaxine or mirtazapine monotherapy)
Drug: Placebo
6 weeks Placebo add-on
Other Name: Sugar pills, mimics Minocycline tablet

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 with es-/citalopram, venlafaxine or mirtazapine monotherapy (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456948


Contacts
Contact: Julian Hellmann-Regen, MD Julian.Hellmann@charite.de
Contact: Vera Clemens, MD Vera.Clemens@charite.com

Locations
Germany
Heidelberg University Hospital, Department of Psychiatry Recruiting
Heidelberg, Baden-Württemberg, Germany, 69115
Contact: Egle Simulionyte, MD    +49-(0)6221-56-5472      
Principal Investigator: Oliver Gruber, MD         
Sub-Investigator: Daniela Roesch-Ely, MD         
Department of Psychiatry, Universitiy Hospital Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Johannes Kornhuber, MD    +49 (0)9131 85-33001      
Principal Investigator: Johannes Kornhuber, MD         
Sub-Investigator: Juan Manuel Maler, MD         
Department of Psychiatry, LMU Munich Recruiting
Munich, Bavaria, Germany, 80336
Contact: Thomas Görlitz    +49 (0)89-4400-55861    thomas.goerlitz@med.uni-muenchen.de   
Principal Investigator: Cornelius Schüle, MD         
Sub-Investigator: Frank Padberg, MD         
Max Planck Institute of Psychiatry Recruiting
Munich, Bavaria, Germany, 80804
Contact: Marcus Ising, PG    +49 (0)89 306221    ising@psych.mpg.de   
Contact: , MD         
Principal Investigator: Martin Keck, MD         
Sub-Investigator: Susanne Lucae, MD         
Department of Psychiatry, Universitiy Hospital Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Thomas Baghai, MD    +449 (0)941 941-1004      
Principal Investigator: Thomas Baghai, MD         
Sub-Investigator: Thomas Wetter, MD         
Department of Psychiatry, University Medical Center Göttingen Recruiting
Göttingen, Lower Saxony, Germany, 37075
Contact: Roberto Goya-Maldonado, MD    +49 (0) 551 39-22244    roberto.goya@med.uni-goettingen.de   
Principal Investigator: Roberto Goya-Maldonado, MD         
Sub-Investigator: Jens Wiltfang, MD         
Department of Psychiatry, Charité - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Julian Hellmann, MD       Julian.Hellmann@charite.de   
Contact: Vera Clemens, MD       Vera.Clemens@charite.de   
Principal Investigator: Isabella Heuser, MD, PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Isabella Heuser, MD, PhD Chair: Department of Psychiatry Charité - Campus Benjamn
  More Information

Responsible Party: Isabella Heuser, MD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02456948     History of Changes
Other Study ID Numbers: 01EE1401F
First Submitted: May 27, 2015
First Posted: May 29, 2015
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Isabella Heuser, Charite University, Berlin, Germany:
treatment resistant depression
inflammation
microglia
minocycline

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents