Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03947827
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2019-05-09
Brief Title:
Minocycline as Adjunctive Treatment for Treatment Resistant Depression
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Minocycline as Adjunctive Treatment for Treatment Resistant Depression a Double Blind Placebo-controlled Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINDEP2
Brief 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 minocyclines efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action
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 minocyclines efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None