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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Minocycline
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring treatment resistant depression, inflammation, microglia, minocycline

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Heidelberg University Hospital, Department of Psychiatry
  • Department of Psychiatry, Universitiy Hospital
  • Department of Psychiatry, LMU Munich
  • Max Planck Institute of Psychiatry
  • Department of Psychiatry, Universitiy Hospital
  • Department of Psychiatry, University Medical Center Göttingen
  • Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
  • Department of Psychiatry, Charité - Campus Benjamin Franklin
  • Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocycline

Placebo

Arm Description

Minocycline and standard antidepressant treatment

Placebo and standard antidepressant treatment

Outcomes

Primary Outcome Measures

Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2015
Last Updated
October 16, 2020
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02456948
Brief Title
Adjunct Minocyline in Treatment-resistant Depression
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
August 7, 2020 (Actual)
Study Completion Date
August 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
treatment resistant depression, inflammation, microglia, minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Arm Description
Minocycline and standard antidepressant treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo and standard antidepressant treatment
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Solodyn, Minocin
Intervention Description
6 weeks 200mg/day Minocycline add-on
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pills, mimics Minocycline tablet
Intervention Description
6 weeks Placebo add-on
Primary Outcome Measure Information:
Title
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time Frame
6 weeks
Title
HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)
Time Frame
6 weeks
Title
BDI-Scale (Beck Depression Inventory, Self Rating Scale)
Time Frame
6 weeks
Title
CGI-Scale (Clinical Global Impressions Scale)
Time Frame
6 weeks
Title
SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)
Time Frame
6 weeks
Title
Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells
Time Frame
6 weeks
Title
Protein levels of various inflammation-associated markers in patient sera
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Heuser, MD, PhD
Organizational Affiliation
Chair: Department of Psychiatry Charité - Campus Benjamn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heidelberg University Hospital, Department of Psychiatry
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Department of Psychiatry, Universitiy Hospital
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Department of Psychiatry, LMU Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Max Planck Institute of Psychiatry
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany
Facility Name
Department of Psychiatry, Universitiy Hospital
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Department of Psychiatry, University Medical Center Göttingen
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Facility Name
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
City
Aachen
Country
Germany
Facility Name
Department of Psychiatry, Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt
City
Frankfurt
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunct Minocyline in Treatment-resistant Depression

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