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Minocycline for Treatment-Resistant Depression (MINDEP2 Trial)

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

MINDEP2 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.Check my eligibility

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.See study design

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.

MINDEP2 Trial 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.

MINDEP2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depressive symptoms

Secondary outcome measures

Anxiety symptoms

Clinician-rated illness severity

Remission rate

+2 more

MINDEP2 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,344 Total Patients Enrolled

The Physicians' Services Incorporated FoundationOTHER

162 Previous Clinical Trials

26,655 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to people who are over the age of 60 years old?

"The target participants for this study are adults that have not yet reached their octogenarian years."

Answered by AI

How can I join this clinical research program?

"This clinical trial is looking for 100 participants that suffer from depression and are between 18 and 80 years old. Most notably, candidates should meet the following criteria: If female of childbearing potential, currently on a medically acceptable form of birth control, Outpatients, voluntary and capable to consent, DSM-5 diagnosis of non-psychotic MDD, single or recurrent, Baseline HRSD score > 14, ATHF total score > 3, Current adequate trial of one of the following standard antidepressants: Escitalopram, Citalopram, Sertraline, Venlafaxine, Dulox"

Answered by AI

Does Active have the potential to harm patients?

"Active has undergone Phase 3 clinical trials, meaning that there is some data supporting efficacy as well as multiple rounds of data supporting safety. As such, our team at Power rates Active as a 3 on our safety scale."

Answered by AI

How many test subjects are being asked to participate in this experiment?

"That is accurate, the online information from clinicaltrials.gov does state that the research team is currently looking for volunteers. The trial was first advertised on February 1st, 2020 and updated for the last time on August 30th, 2022. They are hoping to find 100 individuals total from a single location."

Answered by AI

Are there any remaining vacancies in this research program?

"That is accurate. The clinical trial was originally posted on 2/1/2020 and was last edited on 8/30/2022. The study is recruiting for 100 patients at 1 locations."

Answered by AI

What is the typical application for Active?

"Active can be used to help treat rocky mountain spotted fever, q fever, and dental root planing."

Answered by AI

Are there precedent studies for the use of Active?

"20 clinical trials are still underway to investigate Active with 5 of those in the third and final Phase. Most of these studies taking place in Guangzhou, Guangdong; however, there are 36 research sites in total."

Answered by AI

Recent research and studies

BMC PsychiatryJournal

Minocycline as Adjunctive Treatment for Treatment-resistant Depression: Study Protocol for a Double Blind, Placebo-controlled, Randomized Trial (MINDEP2)

Husain, Muhammad Ishrat, Clare Cullen, Madeha Umer, Andre F. Carvalho, Stefan Kloiber, Jeffrey H. Meyer, Abigail Ortiz, et al.. 2020. “Minocycline as Adjunctive Treatment for Treatment-resistant Depression: Study Protocol for a Double Blind, Placebo-controlled, Randomized Trial (MINDEP2)”. BMC Psychiatry. Springer Science and Business Media LLC. doi:10.1186/s12888-020-02553-9.

clinicaltrials.govStudy

Minocycline as Adjunctive Treatment for Treatment Resistant Depression

Ishrat Husain 2020. "Minocycline as Adjunctive Treatment for Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03947827.

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