Trial document




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  DRKS00009444

Trial Description

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Title

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

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Trial Acronym

Mino-TRD

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URL of the Trial

https://psychiatrie.charite.de/forschung/neurobiologisches_labor/studieninformation_fuer_interessenten_der_mino_trd_studie/

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Brief Summary in Lay Language

This study examines the antidepressant efficacy of the antibiotic minocycline as an adjunct therapy to an antidepressant standard treatment for patients with unipolar major depressive disorder (MDD).

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Brief Summary in Scientific Language

This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatmentfor patients with unipolar major depressive disorder (MDD).

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Organizational Data

  •   DRKS00009444
  •   2015/12/04
  •   2015/05/27
  •   yes
  •   Approved
  •   15/0229 - EK 11, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2015-001456-29 
  •   NCT02456948  (ClinicalTrials.gov)
  •   4040766 
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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   Minocycline 200mg per day oral (100-0-100mg/day) and standard antidepressant treatment in a sufficient dosing; standard antidepressant treatment starts at least 6 weeks before the beginning of the study and will be continued during the study; Duration of the minocycline intake: 6 weeks
  •   Placebo and standard antidepressant treatment in a sufficient dosing; standard antidepressant treatment starts at least 6 weeks before the beginning of the study and will be continued during the study; Duration of the placebo intake: 6 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Change in MADRS score (Montgomery-Åsberg Depression Rating Scale) from
baseline to week 7, weekly Ratings.
Measurement of the severity of depressive symptoms.

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Secondary Outcome

Remission or Response via MADRS;

HAM-D-17-Scale (17-item Hamilton Depression Rating Scale, external-assessment of the severity of depressive symptoms)

BDI-Scale (Beck Depression Inventory, Self Rating Scale, Assessment of the severity of depressive symptoms)

CGI-Scale (Clinical Global Impressions Scale, Assessment of the global severity of the illness);

SCL-90-R (Symptom Checklist 90-R, Self Rating Scale, Rating of the subjective impairment by disease symptoms)

TMT A, B (Trail Making Tests A and B, Rating of the executive function).



MADRS; HAM-D-17, BDI, CGI: weekly Ratings
SCL 90: Week 1,4,7
TMT A, B: Week 1, 7


Proteomic- and Transcriptomic changes, Inflammation-associated markers (Rating: Week 1,4,7)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/20
  •   160
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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 prior to baseline without a sufficient response. Simultanous Treatment with other ADs or Quetiapin/Aripirazol, administered in antidepresssive indication, is possible. All ADs must have been administered for at least 6 weeks in the current episode and at a
stable regimen for at least 14 days prior to baseline .

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Exclusion Criteria

•prevalence of neurodegenerative disorder
•prevalence of a neurological disorder that caused depression
•prevalence of any severe, unstable general medical condition, including chronic inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
• Depressive symptoms are based on any other axis I disorder
•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, liver or kidney dysfunction
•history of autoimmune disease (allowed: Hashimotos thyroiditis)
•clinically significant laboratory abnormalities
•current medication with anti-inflammatory substances (NSAIDs, corticosteroids) or retinoids
• any adverse effect as a consequence of a former tetracycline intake inclusive any hypersensitivity reactions due to tetracycline or any known tetracycline incompatibility
• Involuntary commitment
•Acute suicidality tendency or suicide attempts during the current episode or in the last 5 years

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Addresses

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    • Charité - Universitätsmedizin Berlin, Sponsorvertretung: Frau Prof. Dr. Dipl.-Psych. Isabella Heuser
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin
    • Mr.  Dr.  Julian  Hellmann-Regen 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Klinik für Psychiatrie und PsychotherapieCharité - Universitätsmedizin BerlinCampus Benjamin Franklin
    • Ms.  Dr  Vera  Clemens 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Projektträger im DLR
    • Heinrich-Kronenstr. 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.