Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 4:52 AM
Study NCT ID:
NCT02533232
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia: A Randomised Placebo-controlled Double-blind Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).
Detailed Description:
The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms.
The secondary objectives are to determine:
* Effects on cognitive functioning.
* Effects on social functioning and quality of life.
* Safety and tolerability.
* Possible additive effects of Minocycline added to TAU
* The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo.
The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.
The secondary objectives are to determine:
* Effects on cognitive functioning.
* Effects on social functioning and quality of life.
* Safety and tolerability.
* Possible additive effects of Minocycline added to TAU
* The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo.
The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.
Study Oversight
Has Oversight DMC:
True
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?: