Adjunct Minocyline in Treatment-resistant Depression

• Status: Completed
• Trial end date: 2020-08-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Minocycline

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)