Adjunct Minocyline in Treatment-resistant Depression
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Minocycline (Drug); Placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s): Isabella Heuser, MD, PhD, Principal Investigator, Affiliation: Chair: Department of Psychiatry Charité - Campus Benjamn
Overall contact: Julian Hellmann-Regen, MD, Email: Julian.Hellmann@charite.de
Summary
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 with es-/citalopram, venlafaxine or mirtazapine must have been administered at
a sufficient dose per the Massachusetts General Hospital Antidepressant Treatment
History Questionnaire (MGH ATRQ) 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 or a neurological disorder known to be
associated with depression
- prevalence of any severe, unstable general medical condition, including chronic
inflammatory disease such as rheumatoid arthritis or inflammatory bowel disease
- prevalence of other axis I disorders, including current or past history of bipolar
- 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
- positive serology for hepatitis C or B
- clinically significant abnormalities in 12-lead ECG
- clinically significant laboratory abnormalities (outside normal ranges)
- current medication with anti-inflammatory substances (NSAIDs, corticosteroids)
Locations and Contacts
Julian Hellmann-Regen, MD, Email: Julian.Hellmann@charite.de
Department of Psychiatry, Charité - Campus Benjamin Franklin, Berlin 12203, Germany
Additional Information
Starting date: August 2015
Last updated: May 27, 2015
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