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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

Page last updated: August 23, 2015

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