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Minocycline for Treatment-Resistant Depression (MINDEP2 Trial)

Phase 3
Waitlist Available
Led By Ishrat Husain, MBBS, MD(Res.)
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the SCID-5
Currently taking one of the following standard antidepressants: Escitalopram, Citalopram, Sertraline, Venlafaxine, Duloxetine, Mirtazapine or Bupropion
Must not have
DSM-5 diagnosis of borderline personality disorder (BPD)
Have Myasthenia Gravis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether minocycline, an antibiotic, can help people with treatment-resistant depression who haven't been helped by other medications.

Who is the study for?
This trial is for adults aged 18-80 with non-psychotic major depressive disorder (MDD) who haven't responded to standard antidepressants. Participants must have a certain level of depression severity and be stable on their current medication dose. Women of childbearing age should use effective birth control, and all participants must be able to follow the study schedule.
What is being tested?
The trial tests if minocycline can help people with treatment-resistant depression when added to usual treatments. It's a double-blind study, meaning neither doctors nor patients know who gets minocycline or placebo. Assessments include depression scales and quality of life measures over 12 weeks, starting at a low dose that increases after two weeks.
What are the potential side effects?
Potential side effects from minocycline may include dizziness, fatigue, digestive issues like nausea or diarrhea, changes in skin color, sun sensitivity, tooth discoloration in children but less likely in adults due to permanent teeth being formed already.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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I am currently taking a standard antidepressant.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with borderline personality disorder.
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I have Myasthenia Gravis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depressive symptoms
Secondary study objectives
Anxiety symptoms
Clinician-rated illness severity
Remission rate
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Minocycline will start at an oral dose of 100mg daily and will be increased after one week to 100mg twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules will start at one capsule daily, and will be increased after one week to one capsule twice daily

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
372 Previous Clinical Trials
82,759 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,327 Total Patients Enrolled
Ishrat Husain, MBBS, MD(Res.)Principal InvestigatorCAMH

Media Library

Active Clinical Trial Eligibility Overview. Trial Name: NCT03947827 — Phase 3
Major Depressive Disorder Clinical Trial 2023: Active Highlights & Side Effects. Trial Name: NCT03947827 — Phase 3
Active 2023 Treatment Timeline for Medical Study. Trial Name: NCT03947827 — Phase 3
Major Depressive Disorder Research Study Groups: Active, Placebo
~1 spots leftby Jan 2025
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