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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02456948
Recruitment Status : Active, not recruiting
First Posted : May 29, 2015
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Isabella Heuser, 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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Minocycline Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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)
Actual Study Start Date : January 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocycline
Minocycline and standard antidepressant treatment
Drug: Minocycline
6 weeks 200mg/day Minocycline add-on
Other Names:
  • Solodyn
  • Minocin

Placebo Comparator: Placebo
Placebo and standard antidepressant treatment
Drug: Placebo
6 weeks Placebo add-on
Other Name: Sugar pills, mimics Minocycline tablet




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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)

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


Locations
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Germany
Heidelberg University Hospital, Department of Psychiatry
Heidelberg, Baden-Württemberg, Germany, 69115
Department of Psychiatry, Universitiy Hospital
Erlangen, Bavaria, Germany, 91054
Department of Psychiatry, LMU Munich
Munich, Bavaria, Germany, 80336
Max Planck Institute of Psychiatry
Munich, Bavaria, Germany, 80804
Department of Psychiatry, Universitiy Hospital
Regensburg, Bavaria, Germany, 93053
Department of Psychiatry, University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
Aachen, Germany
Department of Psychiatry, Charité - Campus Benjamin Franklin
Berlin, Germany, 12203
Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt
Frankfurt, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Isabella Heuser, MD, PhD Chair: Department of Psychiatry Charité - Campus Benjamn

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Responsible Party: Isabella Heuser, MD, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02456948    
Other Study ID Numbers: 01EE1401F
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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:
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Depressive Disorder
Depression
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents