Adjunct Minocyline in Treatment-resistant Depression

NCT02456948 | Completed Phase 2 DMC

• 1 other identifier: 01EE1401F
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 9

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).

Conditions

Major Depressive Disorder

Keywords

treatment resistant depression; inflammation; microglia; minocycline

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (7)

• Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)

  6 weeks

• HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)

  6 weeks

• BDI-Scale (Beck Depression Inventory, Self Rating Scale)

  6 weeks

• CGI-Scale (Clinical Global Impressions Scale)

  6 weeks

• SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)

  6 weeks

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline and standard antidepressant treatment

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Placebo and standard antidepressant treatment

Drug: Placebo

Interventions

Minocycline DRUG

6 weeks 200mg/day Minocycline add-on

Also known as: Solodyn, Minocin

Minocycline

Placebo DRUG

6 weeks Placebo add-on

Also known as: Sugar pills, mimics Minocycline tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (9)

Heidelberg University Hospital, Department of Psychiatry

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Department of Psychiatry, Universitiy Hospital

Erlangen, Bavaria, 91054, Germany

Location

Department of Psychiatry, LMU Munich

Munich, Bavaria, 80336, Germany

Location

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

Location

Department of Psychiatry, Universitiy Hospital

Regensburg, Bavaria, 93053, Germany

Location

Department of Psychiatry, University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen

Aachen, Germany

Location

Department of Psychiatry, Charité - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt

Frankfurt, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Inflammation; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Isabella Heuser, MD, PhD

  Chair: Department of Psychiatry Charité - Campus Benjamn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2015
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)