Adjunct Minocyline in Treatment-resistant Depression

NCT ID: NCT02456948

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-08-07

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Minocycline

Minocycline and standard antidepressant treatment

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

6 weeks 200mg/day Minocycline add-on

Placebo

Placebo and standard antidepressant treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

6 weeks Placebo add-on

Interventions

Minocycline

6 weeks 200mg/day Minocycline add-on

Intervention Type: DRUG

Placebo

6 weeks Placebo add-on

Intervention Type: DRUG

Other Intervention Names

Solodyn; Minocin; Sugar pills, mimics Minocycline tablet

Eligibility 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 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Isabella Heuser

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabella Heuser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair: Department of Psychiatry Charité - Campus Benjamn

Locations

Heidelberg University Hospital, Department of Psychiatry

Heidelberg, Baden-Wurttemberg, Germany

Department of Psychiatry, Universitiy Hospital

Erlangen, Bavaria, Germany

Department of Psychiatry, LMU Munich

Munich, Bavaria, Germany

Max Planck Institute of Psychiatry

Munich, Bavaria, Germany

Department of Psychiatry, Universitiy Hospital

Regensburg, Bavaria, Germany

Department of Psychiatry, University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

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

Aachen, , Germany

Department of Psychiatry, Charité - Campus Benjamin Franklin

Berlin, , Germany

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

Frankfurt, , Germany

Countries

Germany

Other Identifiers

01EE1401F

Identifier Type: -

Identifier Source: org_study_id