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

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ClinicalTrials.gov Identifier: NCT02456948
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Isabella Heuser, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE May 27, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date August 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunct Minocyline in Treatment-resistant Depression
Official Title  ICMJE A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Unipolar Major Depressive Disorder (MDD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Minocycline
    6 weeks 200mg/day Minocycline add-on
    Other Names:
    • Solodyn
    • Minocin
  • Drug: Placebo
    6 weeks Placebo add-on
    Other Name: Sugar pills, mimics Minocycline tablet
Study Arms  ICMJE
  • Experimental: Minocycline
    Minocycline and standard antidepressant treatment
    Intervention: Drug: Minocycline
  • Placebo Comparator: Placebo
    Placebo and standard antidepressant treatment
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
168
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
160
Actual Study Completion Date  ICMJE August 7, 2020
Actual Primary Completion Date August 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02456948
Other Study ID Numbers  ICMJE 01EE1401F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Isabella Heuser, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabella Heuser, MD, PhD Chair: Department of Psychiatry Charité - Campus Benjamn
PRS Account Charite University, Berlin, Germany
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP