ClinicalTrials.gg
CompletedNCT03947827MINDEP2Updated Mar 27, 2026

Minocycline as Adjunctive Treatment for Treatment Resistant Depression

A Phase 3 interventional study of Minocycline in Treatment Resistant Depression, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Centre for Addiction and Mental Health · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Depressive Disorder, Treatment-Resistant by Centre for Addiction and Mental Health — 4 open to participants now, 5 under way, none of them phase 3. Depressive Disorder, Treatment-Resistant · Centre for Addiction and Mental Health.

Enrollment
5th of 15
76 · median 40
Started
2020
the only one that year
Phase 3
Only one
of the 15
Registered
5th of 15
by date

Among the 15 studies in Depressive Disorder, Treatment-Resistant by Centre for Addiction and Mental Health, this one is the 5th largest by enrollment, is the only one that started in 2020, is the only one in phase 3, and was the 5th registered.

Depressive Disorder, Treatment-Resistant

448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.

Browse Depressive Disorder, Treatment-Resistant studies →

Open to participants now

4 of the 15 studies in Depressive Disorder, Treatment-Resistant by Centre for Addiction and Mental Health are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 114 Depressive Disorder, Treatment-Resistant studies recruiting now, 26 (23%) set no upper age limit and 76 (67%) stop at 75 or younger; 1 takes children under 18; 13 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Depressive Disorder, Treatment-Resistant by Centre for Addiction and Mental Health, or all of them as a file.
02

Study summary

Major depressive disorder (MDD) is a leading cause of disability worldwide. Up to 50% of patients experience treatment resistant depression (TRD), which accounts for a vast majority of disease burden. Current medications for TRD have limited efficacy and can be associated with intolerable side effects. Therefore, there is a need for finding new treatment targets. Accumulating evidence suggests some patients with MDD including those with TRD, display brain inflammation. Thus, patients with TRD may benefit from medications that can reduce this inflammation. Minocycline is an antibiotic which can cross the blood-brain barrier and has effects on several systems implicated in depression. The principal investigator led the first pilot study of minocycline as an add-on treatment in TRD demonstrating that it led to a significant reduction in depressive symptoms compared to placebo and these findings require replication in a larger sample to confirm the efficacy and tolerability of this treatment approach.

This study is a 12 week, double-blind, placebo-controlled trial of minocycline as add-on treatment for patients suffering from a major depressive episode who have failed to respond to antidepressant treatment, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) and the Antidepressant Treatment History Form (ATHF) at screening. After screening and randomization to the two parallel arms of the trial, 50 patients will receive minocycline added to treatment as usual (TAU) and 50 patients will receive placebo added to TAU. Clinical assessment will include the Hamilton Depression Rating Scale (HRSD-17), Clinical Global Impression scale (CGI), World Health Organization Quality of Life Short Form (WHOQOL-BREF), and Generalized Anxiety Disorder scale (GAD-7), administered at each study visit (baseline, week 2, 6, and 12). Side effects checklists will be undertaken at each visit. Minocycline will be started at 100 mg once daily and will be increased to 100 mg twice daily at two weeks. Secondary outcomes include inflammatory biomarkers measured at baseline, weeks 6 and 12.

This trial will provide further evidence of minocycline's efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action.

03

Conditions studied

  • Treatment Resistant Depression

Keywords

  • Treatment Resistant Depression
  • Minocycline
  • Neuroinflammation
  • Microglial Activation
  • Biomarker
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Outpatients
  2. Voluntary and competent to consent to treatment
  3. diagnosis of non-psychotic MDD, single or recurrent, based on the SCID-5
  4. Male or female aged between 18-80
  5. Total score > 3 on ATHF
  6. Baseline HRSD-17 score > 14
  7. Able to adhere to study schedule
  8. If female of , currently on a medically acceptable form of (oral contraceptives, contraceptive injections, IUD, contraceptive patch, male partner sterilization, abstinence, or barrier methods plus spermicide)
  9. Currently taking one of the following standard antidepressants: Escitalopram, Citalopram, Sertraline, Venlafaxine, Duloxetine, Mirtazapine or Bupropion
  10. Been on same dose of all psychotropic medications for > 4 weeks prior to enrolment

Exclusion criteria

Exclusion Criteria:

  1. substance use disorder within past 3 months, moderate or severe, based on SCID-5
  2. Concomitant major unstable medical illness
  3. Pregnancy or intent to become pregnant during study period
  4. DSM-5 diagnosis of psychotic disorder, bipolar disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD) within last year
  5. DSM-5 diagnosis of borderline personality disorder (BPD)
  6. Possible or probable dementia
  7. Prior or current intolerance or to tetracyclines
  8. Abnormal readings in hematology, liver, or renal function tests
  9. Have Myasthenia Gravis
  10. Concomitant treatment with anticoagulants, diuretics, retinoids, ergot alkaloids, antacids containing aluminium/calcium/magnesium, bismuth and zinc salts, or quinapril
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    Active

    Minocycline will start at an oral dose of 100mg daily and will be increased after one week to 100mg twice daily.

    Drug: Minocycline

  • Placebo comparator
    Placebo

    Placebo capsules will start at one capsule daily, and will be increased after one week to one capsule twice daily

    Drug: Minocycline

Interventions

  • Participants will be randomized to receive either Minocycline or placebo added to standard oral antidepressants.

    Also known as: Apo-Minocycline

06

What researchers measure

Primary outcomes

  1. Depressive symptoms

    Changes from baseline to week 12 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).

    Time frame: 12 weeks

Secondary outcomes

  1. Response rate

    Reduction of 50% or more in HRSD score from baseline to week 12

    Time frame: 12 weeks

  2. Remission rate

    Final HRSD score \< 8

    Time frame: 12 weeks

  3. Anxiety symptoms

    Changes from baseline to week 12 in Generalized Anxiety Disorder scale (GAD-7)

    Time frame: 12 weeks

  4. Self-reported perception of quality of life

    Changes from baseline to week 12 in World Health Organization Quality of Life Short Version (WHOQOL-BREF)

    Time frame: 12 weeks

  5. Clinician-rated illness severity

    Changes from baseline to week 12 in Clinical Global Impression scale (CGI)

    Time frame: 12 weeks

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M6J 1H4, Canada
08

References and documents

Publications

  • Husain MI, Cullen C, Umer M, Carvalho AF, Kloiber S, Meyer JH, Ortiz A, Knyahnytska Y, Husain MO, Giddens J, Diniz BS, Wang W, Young AH, Mulsant BH, Daskalakis ZJ. Minocycline as adjunctive treatment for treatment-resistant depression: study protocol for a double blind, placebo-controlled, randomized trial (MINDEP2). BMC Psychiatry. 2020 Apr 15;20(1):173. doi: 10.1186/s12888-020-02553-9. PubMed 32295565 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Jan 2025, 59 months.

Of 24 phase 3 interventional studies under Depressive Disorder, Treatment-Resistant, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's 59 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2019
First posted
May 13, 2019
StartActual
Feb 1, 2020
Primary completionActual
Jan 7, 2025
CompletionActual
Jan 7, 2025
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03947827
Collaborators
The Physicians' Services Incorporated Foundation
Responsible party
Ishrat Husain (Clinician Scientist, Centre for Addiction and Mental Health) — Principal investigator
First posted
May 13, 2019
Start date
Feb 1, 2020
Primary completion
Jan 7, 2025
Completion
Jan 7, 2025
Last update
Mar 27, 2026

Study contacts

Ishrat Husain, MBBS, MD(Res.)
principal investigator · CAMH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Minocycline

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